Medical Device made Easy Podcast (easymedicaldevice)
Explorez tous les épisodes de Medical Device made Easy Podcast
| Date | Titre | Durée | |||
|---|---|---|---|---|---|
| 11 Jan 2022 | How to accelerate your Laboratory Test Results? [Christoph Lindner] | ||||
I am sure you were in this situation where you had to execute some Laboratory Tests for the compliance of your medical device and thought that you just need to contact them so they can execute the test. But the reality is different. They may ask you a lot of questions that you don’t understand. So on this podcast episode, we help you define the best process for you to approach a Laboratory with the support of Christoph Lindner from TÜV SÜD. He will share with us his knowledge and tips for you to accelerate your lab test results. ► Who is Christoph Lindner? Christoph Lindner is the Team Leader for Medical Device testing at TÜV SÜD. He has a Ph.D. in Organic Chemistry. His career in the industry was on ophthalmology products and also on Laboratory testing. Before being in charge of the Medical Device testing at TÜV SÜD he first became a Notified Body Auditor which helps him to have a clear understanding of the regulatory requirements. ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He is now in charge of the consulting firm Easy Medical Device in Switzerland, Belgium, and the UK and developed many ways to deliver knowledge through Videos, podcasts, online courses… He offers also the service of an Authorized Representative for his customers. ► Links: Christoph Lindner LinkedIn Profile: https://www.linkedin.com/in/christoph-lindner-a274aba1/ TÜV SÜD Laboratory Test Services: https://podcast.easymedicaldevice.com/wp-content/uploads/2022/01/TUV-SUD-testing-services_one-pager.pdf TÜV SÜD Website: https://www.tuvsud.com/en-us/services/testing EU MDR 2017/745 Green Belt Training: https://easymedicaldevice.com/gb | |||||
| 18 Jan 2022 | How to interview QA RA candidates with Mitch Robbins | ||||
If you are a Quality or Regulatory affairs hiring manager then you may need to understand how to interview your candidates. I have asked Mitch Robbins from the Anthony Michael Group which is a Recruiting Agency to help us with some techniques. Mitch Robbins will explain to you how to prepare prior to the interview, what kind of information you need to identify during the interview and what is the activities after. If you follow that, you will have a high chance to recruit the right candidate for your organization. I hope this will help you. Who is Mitch Robbins? Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links from the Video Mitch´s Linkedin Profile: https://www.linkedin.com/in/mitchrobbins/ The Anthony Michael Group: https://theanthonymichaelgroup.com Episode: Be the best candidate ever: https://podcast.easymedicaldevice.com/38/ | |||||
| 25 Jan 2022 | MDCG 2021-27 Placing on the market and Importer Re-labelling with Erik Vollebregt | ||||
The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. Erik Vollebregt, a lawyer at Axon Lawyers is helping us to understand the problem some vocabulary used can generate. In this case, we will focus on 2 of the elements: - Placing on the market - Importer relabelling. Don't hesitate to look at the show notes for more details. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses... Links ■ Erik Vollebregt Linkedin Profile: https://www.linkedin.com/in/erikvollebregt/ ■ Axon Lawyers: https://www.axonlawyers.com/ ■ Medical device legal blog: https://medicaldeviceslegal.com/2021/12/28/mdcg-2021-27-qa-on-importers-and-distributors-sort-of-box-of-chocolates/ ■ MDCG 2021-27: https://ec.europa.eu/health/system/files/2021-12/mdcg_2021-27_en.pdf
| |||||
| 01 Feb 2022 | Medical Device News - February 2022 Regulatory Update | ||||
The February 2022 Regulatory Update contains a lot of information that may help you to maintain your team up-to-date with the new requirements. Agenda:
LINKS IVDR
Training
Divers
Newsletter
Guidance:
Notified Body
PODCAST:
| |||||
| 08 Feb 2022 | Why Design History File (DHF) is so important? [Alexandros Savvidis] | ||||
DHF or Design History File or DMR or DHR or … What does all this mean? We will focus on DHF but we’ll also provide an explanation of the other acronyms. In this episode of the Podcast, Alexandros Savvidis will share with us his experience. He’ll provide some examples. So don’t hesitate to check this episode if you are willing to get more understanding and ask your questions in the comments. Who is Alexandros Savvidis? Alexandros Savvidis is a Senior Medical Device Specialist active more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles on the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or a team member, or even on cross-functional teams of Life Science Giants. In the last years is his main focus is the implementation of MDR requirements and updates Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
| |||||
| 15 Feb 2022 | How to have a great Management Review? | 00:27:54 | |||
When we talk about Management Review, this is not really obvious how this should be done. In this video, I will try to explain to you what is expected to be seen by an auditor when they ask you to show them your Management Review. I will explain: – What is a Management Review – What you should consider when building your Management Review – Which documents are needed – What are the inputs and outputs with examples. I hope this will be helpful for you. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Social Media to follow
| |||||
| 22 Feb 2022 | Why do you need a Swiss Authorised Representative and Importer? | ||||
Since May 26th, 2021 Switzerland is now considered as non-EU country for Medical Devices. So to sell your products in Switzerland you need a Swiss Authorized Representative and a Swiss Importer. In this episode of the podcast, I will explain to you the reason for all that and the role and responsibility for the Manufacturer wanted to ship its products to Switzerland and the one of the Swiss Importers and Authorised Representative. If you have any questions, reach out to me: info at easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links
| |||||
| 01 Mar 2022 | Medical Device News - March 2022 Regulatory Update | 00:23:42 | |||
HOT TOPICS
TRAINING
WORLDWIDE
GUIDANCES
NOSTALGIA
| |||||
| 08 Mar 2022 | IVDR Class D Common Specification with Andreas Stange [TÜV SÜD] | 00:27:44 | |||
For IVDR products, there is more and more information that is coming. So we make a small summary with Andreas Stange from TÜV SÜD and then we will discuss specifically the Draft Common Specification for certain Class D devices. Andreas will explain to you why we need these common specifications and if this is mandatory. He will also explain the problem that comes now when the transition date for certain devices were extended. Andreas will also invite you to join TÜV SÜD if you are interested to be part of this Notified Body as an auditor. Multiple places in the world are looking for you. I hope this will be informative to you. Who is Andreas Stange? Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD. Product Service. He serves as the global responsibility for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia. Dr. Stange joined TÜV SÜD in 2001 as a medical device expert and had various positions since then in the group. Before taking the current position in March 2017, he served as President & CEO of TÜV SÜD in Japan for eight years. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
| |||||
| 15 Mar 2022 | Which lessons did we learn doing Clinical Evaluations? [Cesare Magri] | ||||
Since MDR is live we get from surprises to surprises. And we wanted in this episode to share with you some lessons learned regarding Clinical Evaluation. You maybe noticed that between MDD and MDR the audit style for CER is different. Even if the requirements are mostly the same. So today we'll try to guide you to be on the safe side with Cesare Magri from Be-on-Clinical. Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. Recently he founded be-on-Clinical together with Stefan Bolleininger in 2020. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links
Social Media to follow
| |||||
| 22 Mar 2022 | How to sell Medical Devices on an Online Platform? [Michael Wetherington] | ||||
Since the implementation of EU MDR, there was a new phenomenon about Medical Device online sales. Online sales see their submissions to platforms like amazon rejected as they do have not all the documentation needed. This is also the same in the US market and it will become the same with EU IVDR when the date of implementation will start. So how do get in compliance? I have interviewed Michael Wetherington who will provide us with some hints on what should be done. If you need any support, don’t hesitate to contact me. I will then forward your request. Who is Michael Wetherington? Michael Wetherington is the Founder of MedicalRegs.com. MedicalRegs.com helps MedTech startups design devices with the applicable requirements in mind. They go further by providing regulatory services for the EU, US, Canada, and ASEAN markets. His background encompasses medical device R&D, accredited testing lab, and Notified Body experience. He is also a mentor at Elemed’s Mentoring Academy. And, when time permits, he likes to sing, play the drums, and the guitar. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 29 Mar 2022 | What are some of the surprises during MDR and IVDR transition? [Erik Vollebregt] | ||||
There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine Agency. So Pharma will take care of this. Is there a possibility that we are moving to a model similar to the FDA? Then another important piece of information came from SNITEM & BVMed. Both are asking for an extension of the EU MDR transition from May 2024 to May 2026. Why and would this be considered by the EU Commission? Let’s ask our preferred lawyer Erik Vollebregt. And I am sure this will help you understand all concepts for EU MDR and IVDR Who is Erik Vollebregt Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 05 Apr 2022 | Medical Device News: April 2022 Regulatory Update | ||||
HOT TOPIC
Events
Notified Bodies
EMD
| |||||
| 12 Apr 2022 | Prepare your audit with a Front Room Back Room | ||||
When you get audited, the configuration Front Room Back Room can help you a lot. But how to prepare for it? How to communicate between them? What are the rules to use this system? I will tell you everything in this Podcast and if you need help don’t hesitate to contact me. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 19 Apr 2022 | How your PMCF is evaluated by your Notified Body? [Matthias Fink] | 00:41:40 | |||
PMCF is something that was existing before with MDD 93/42/EC but this is more in focus now with the new EU MDR 2017/745. In this episode, I have invited Matthias Fink from TÜV SÜD to help us understand some of the mistakes we are making in the creation of our PMCF. He will tell us what to do and how to distinguish between the different PMCF types. Who is Matthias Fink? Board-certified orthopedic and trauma surgeon with 17 years of experience in orthopedic, trauma, and reconstructive surgery and extensive training in cardiovascular and thoracic surgery. Working for TÜV SÜD Product Service in Germany since 2016 as a Clinical Reviewer in the Clinical Centre of Excellence before joining TÜV SÜD America in 2017. Senior Clinical Expert Orthopedic Surgery for the Clinical Centre of Excellence and the Team Manager of the Clinical Focus Team North America. Presenter at national and international conferences and workshops on the clinical requirements and the implementation of the EU MDR. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 26 Apr 2022 | Training Procedure "How to avoid mistakes" with Rod Beuzeval and Katie Cooney | 00:46:00 | |||
The training process can create a lot of non-conformances during audits and this is why we will try to explain to you how to avoid that. Rod and Katie from Trinzo will be helping us to create a compliant training process. We will talk about internal training and also training organized by external companies. We will discuss the way an auditor can find some of the issues. The effectiveness monitoring will also be important to cover. So don’t miss this episode of the podcast. Who is Rod Beuzeval? Rod is a regulatory expert with 24 years’ experience in regulated pharmaceutical and medical device companies and holds a RAPS RAC Global scope certification. Rod develops and routinely delivers training on EU MDR,EU IVDR, MDSAP, ISO 13485, risk management, clinical evaluation and provides consultancy on projects within this realm. Throughout Rods career, he has worked with many medical device and IVD companies, helping them to achieve and maintain compliance. With both industry and notified body experience Rod is able to understand what exactly is needed and how to implement it in an effective manner. Who is Katie Cooney? Katie is the Training Centre of Excellence Lead at Trinzo She has over 15 years of experience in a variety of training roles and has performed these roles across all levels of the business. Her experience has been gained within Multinational Manufacturing including Medical Device, Pharmaceuticals and Automotive. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links from the Video
Social Media to follow
| |||||
| 03 May 2022 | Medical Device News - May 2022 Regulatory Update | ||||
In this episode, I will update you regarding all the changes in the Medical Device Quality and Regulatory Field. Below are all the topics we will discuss during this episode. Don’t miss the latest updates. EU
USA
MEA
ASIA
EVENT
GUIDANCES
NOTIFIED BODIES:
Easy Medical Device Nostalgia:
| |||||
| 10 May 2022 | Certify your Software as a Medical Device with Vivek Thakkar | ||||
Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you. Who is Vivek Thakkar? Regulatory affairs professional with a Master’s degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 17 May 2022 | What happens after the IVDR Date of Application with Colm O’Rourke | ||||
The IVDR 2017/746 will become live on May 26th, 2022 and this will be the big day for a lot of IVD companies. To talk about the situation under IVDR, I have invited Colm O’Rourke from Trinzo to help us. Colm is sharing with us the situation for manufacturers. Also about Notified Bodies. Who is Colm O’Rourke? Colm O’Rourke is a regulatory and quality consultant with 10 years’ experience working in the medical device industry, including notified body, diagnostics manufacturer, and clinical laboratory experience. Colm works with manufacturers to achieve compliance through strategic planning, supporting the development of compliant technical and quality documentation, and assisting with regulatory submissions. Colm also delivers training on a number of topics including EU MDR and IVDR. Colm is a graduate of UCC, Ireland with a BSc in Biomedical Science, and NUI Galway, Ireland with a Dip. in Medical Device Science Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 24 May 2022 | What is the EU Medical Device Situation? with Erik Vollebregt | 00:26:53 | |||
The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast episode with Erik Vollebregt to summarize the discussions that happened. The topics that we will cover are:
Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses... Links
| |||||
| 31 May 2022 | Let's introduce our eQMS Smarteye with Anindya Mookerjea | ||||
Big news, with my partners we have developed an eQMS called SmartEye!!! and we wanted to share with you why an eQMS is needed. For that, I have invited Anindya Mookerjea the CEO of SCube Technologies. We will talk about eQMS solutions and how the idea of SmartEye came. I was part of the development of certain modules and this is really satisfying to see that auditors or customers like them. Don’t forget to ask for a demo. Who is Anindya Mookerjea? Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
| |||||
| 07 Jun 2022 | Medical Device News - June 2022 Regulatory Update | ||||
Here is your Medical Device Regulatory update. This will be focused on the IVDR 2017/746 that went live. So let's update you on some key changes. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses... Links NEWS - Swiss: MRA situation for IVDR; https://ec.europa.eu/health/document/download/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf - Swiss: new IvDV (Ordinance on in-vitro diagnostics): https://www.bag.admin.ch/bag/en/home/medizin-und-forschung/heilmittel/aktuelle-rechtsetzungsprojekte/revision-med-prod-verord-mepv.html ○ Swiss Odiv: https://www.fedlex.admin.ch/eli/cc/2022/291/fr - Swiss: Performance studies of IVD: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/leistungsstudien.html ○https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf - EU: Team NB Survey: https://www.team-nb.org/wp-content/uploads/2022/05/Survey-2021-20220516.pdf - EU: Harmonized standard for IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0729 - EU: Harmonized standard for MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32022D0757 - Italy: Establishment of the National Surveillance Network: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=5894 - Preparing for UKCA marking of Medical Device with Ronald Boumans: https://boumansconsulting.com/expert-center/tip-of-the-week/preparing-for-ukca-marking-of-medical-devices/ - Green Belt Certification June 2022: https://school.easymedicaldevice.com/course/gb19/ NOTIFIED BODY - 3EC International - IVDR 2017/746 https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317359&version_no=3 - TÜV Nord - EU MDR 2017/745: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=317538&version_no=8 - Berlin Cert - EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43955 - Overview NB each stage: https://ec.europa.eu/health/system/files/2022-05/notifiedbodies_overview_en.pdf GUIDANCE - MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR: https://ec.europa.eu/health/document/download/14c2d8dd-8489-4db5-b035-1c174f17fb54_en?filename=mdcg_2022-6.pdf - MDCG 2022-7 Q&A UDI System: https://ec.europa.eu/health/document/download/b5429d14-25a9-4cfc-b059-355388f03e05_en?filename=mdcg_2022-7_en.pdf - MDCG 2022-8 IVD Legacy devices: https://ec.europa.eu/health/document/download/76f9983e-164c-45f1-b2b9-c9e5050cefe9_en?filename=mdcg_2022-8_en.pdf - MDCG 2022-9 Summary of safety and performance template: https://ec.europa.eu/health/document/download/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf - MDCG 2022-10 Q&A interface 536/2014 on clinical trials for medicinal products for human use and IVDR: https://ec.europa.eu/health/document/download/59abcc81-fd32-4546-a340-24c8fad4e2ac_en?filename=mdcg_2022-10_en.pdf PODCAST - Episode 179 - How to certify your Software as a Medical Device? With Vivek Thakkar: https://podcast.easymedicaldevice.com/179/ - Episode 180 - What happens after the IVDR Date of Application with Colm O'Rourke: https://podcast.easymedicaldevice.com/180/ - Episode 181 - What to learn about the EU Medical Device Situation? https://podcast.easymedicaldevice.com/181/ -Episode 182- Let's introduce our eQMS Smarteye with Anindya Mookerjea: https://podcast.easymedicaldevice.com/182/ | |||||
| 14 Jun 2022 | How to avoid these common mistakes on your Quality System? [Karandeep Badwal] | 00:28:39 | |||
In this episode, Karandeep Badwal will introduce you to the common mistakes that we can see within your company for Quality and Regulatory affairs.
Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links
Social Media to follow
| |||||
| 21 Jun 2022 | Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu] | ||||
When we think of ISO 13485 certificate we mainly associate it with Medical Device manufacturers. But this can be also associated with other Medical Device Economic Operators. In this episode, Cristina Miroescu (Compliance Director at Sofmedica) will explain to us why Sofmedica decided to be ISO 13485 certified. You'll hear about their journey with the Plus and Minus. We are sure this may help you understand the process of certification if you are an importer or distributor. Who is Cristina Miroescu? Cristina joined SofMedica in 2000 as the first regulatory person preparing files for medicinal product and medical devices registration. Later on, as Regulatory Manager her role was to integrate the legal provisions and regulations into the company’s business strategy. She used to manage quality management systems, vigilance, pharmacovigilance, regulatory, compliance, and warehouse management. As a Group Compliance Director Cristina is responsible to ensure the compliance of the company’s activity with the applicable legislation and requirements with a focus on contributing to building a quality culture of integrity, transparency, and honesty. An important part of Cristina’s activity was focused between 2010 – 2015 in the medical services field in another company of SofMedica group when she was managing the quality management system, permits obtaining and maintenance for 15 dialysis centers in Romania. Cristina holds a bachelor’s degree in Pharmacy. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links
| |||||
| 28 Jun 2022 | Attention! 1 year before UKCA is the law for Medical Devices in the UK | ||||
This episode will alert you about the UKCA deadline for the UK market. So if you are selling products to the UK or if you plan to, you need to listen to what Adam Rae will tell you. We will mention the rules for UKCA, the documentation needed for the Approved Body situation, and also the Northern Ireland Situation. So no need to read all the regulations, we will summarize the situation here and you will need to act immediately after that. Who is Adam Rae? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. Who Is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
| |||||
| 05 Jul 2022 | Medical Device news - July 2022 Regulatory Update | ||||
This month the Regulatory update will contain a lot regarding Artificial intelligence for medical devices. All the links that are mentioned can be downloaded from the link below. Don’t hesitate to contact Easy Medical Device if you have a question on Quality and Regulatory Affairs for medical devices. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Links from the Video Download the July 2022 Regulatory Update document: https://mailchi.mp/easymedicaldevice/july2022 Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 12 Jul 2022 | Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) | ||||
During my visit to the Medtech Europe Forum in Barcelona in May 2022, I had the chance to interview key people in the industry. I am sharing these interviews:
All the LinkedIn links are below. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand the Medical Device Regulations worldwide. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Monir is also a partner with the project Scube Smarteye which developed an eQMS specific for the Medical Device industry. Check the link below. Links
Social Media to follow
| |||||
| 19 Jul 2022 | AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt] | 00:36:07 | |||
If you are working in the development of Software, then this is maybe something that will be interesting for you. The EU is preparing legislation for Artificial Intelligence and we will talk with Erik Vollebregt about the potential compatibility with the EU MDR 2017/745 This new legislation is not focused on Medical Devices but on all software that may contain AI. So if you are impacted, learn what will maybe come within your scope soon. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Recently, Monir is becoming a partner of Scube Technologies for the creation of the eQMS Scube SmartEye specialized for Medical Device companies. Check the link below. Links
Social Media to follow
| |||||
| 26 Jul 2022 | Do you need a Cleanroom for your Medical Devices? [Philippe Bourbon] | 00:33:59 | |||
Cleanroom is an equipement that a lot of Medical Device manufacturer need to have. But do you really need it? How much does it cost? How to qualify it? How to maintain it? Philippe Bourbon from Groupe Icare Laboratory will help us understand all that. Check also the summary provided as a download. Who is Philippe Bourbon? Physician, passionate about topics related to particulate, microbiological and chemical contamination on industrial sites and health sectors. 30 years of experience, knowledge in a Cofrac and cGMP / BPF environment, Consulting / Training, Expert in contamination control, and sterilization processes, Sales, Technical Developments, Management of technicians, managers and salespeople , Activity Manager. Expertises: Sterilization by heat, S.I.P., Ethylene oxide, depyrogenation, cleanrooms and controlled environment, microbiological and chemical confinement, climatic and thermostatic chambers, compressed gas Pharmaceutical Regulation (GMP / cGMP), Medical Devices, Standards (ISO14644, ISO17665, FDX15-140, …) Diagnosis / Consulting / Validation strategy / Qualifications / Audits / Trouble shooting Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now made the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 09 Aug 2022 | When you think “510k” but FDA says “DeNovo” with Spencer Jones | 00:37:14 | |||
This episode will explain to you the journey of the company Lineus Medical when they tried to register their products in the USA. Initially, they prepared the product to be registered with the 510k Regulatory Pathway but the FDA did not agree and said that they should go through DeNovo. So Spencer Jones who founded the company will tell us how they have done that and he will also give some tips on how he would have done it today if he had to restart again. So benefit from his journey to learn how you should do it. Who is Spencer Jones? Spencer worked for three years in direct patient care as a Certified Nursing Assistant, Licensed Practical Nurse, and as a Registered Nurse. Frustrated with the inefficiencies plaguing the healthcare system, he was determined to improve the delivery of healthcare. While still working as a nurse in the clinical setting, Spencer identified opportunities where improvement was needed around IV complication prevention. This led to the creation of SafeBreak® Vascular and the founding of Lineus Medical in 2015. Spencer graduated from the University of Arkansas with a Bachelor in the Science of Nursing. Spencer is on the Fayetteville Innovation Council and was the Entrepreneur in Residence for the Hub X Life Sciences Accelerator for 2016. He has three issued U.S. patents and several others pending. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 02 Aug 2022 | How to create a Technical Documentation? [EU MDR and IVDR] | 00:31:04 | |||
The creation of a Technical File or Technical Documentation for CE marking is really a challenge sometimes. After successfully passing audits with my customers, I want to share with you some best practices to create your Technical Documentation. I will even explain to you how to reference your annexes or what to do with the GSPR. So don’t miss it. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links
Social Media to follow
| |||||
| 16 Aug 2022 | Why don't you discontinue correctly your Medical Devices? | 00:40:15 | |||
This is really a good question. Sometimes, we are looking at the portfolio of some companies and ask "How many products on this portfolio are sold in less than 5 units per year" One company with 1200 references showed me an excel sheet with 500 references that are available but with really low volume of sales. This cost stock, regulatory update work, continuous improvement... So let's talk with Alexandros Saavidis about Discontinuation and I hope this will convince you to embrace this practice. Who is Alexandros Savvidis? Alexandros Savvidis is a Senior Medical Device Specialist active for more than 17 years in multiple areas including Regulatory Affairs, Quality Management, R&D, Sales, Technical Support & Analysis. After his studies in Biomedical Engineering, he has worked in the medical devices as also the pharma packaging industry across Europe in Germany, Switzerland, Netherlands, UK, and Greece. He has organized and contributed as an RA Specialist to various successful international certifications of medical devices of all classes. Alexandros has gained one overall experience and deep understanding through his various roles in the full norm compliant development and certification process, like many other aspects like GMP, quality, risk management, vigilance, or clinical evaluations. He has worked on small, middle-size companies alone or as a team member, or even on cross-functional teams of Life Science Giants. In the last years, his main focus is the implementation of MDR requirements and updates Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses... Links
Social Media to follow
| |||||
| 23 Aug 2022 | The New Blue Guide - What is the impact to the Medical Device Industry? | 00:37:31 | |||
The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of the situation in Switzerland. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company is also acting as Authorized Representative for the EU, UK, and Switzerland? Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 30 Aug 2022 | SaMD or SiMD - How to create a Design Dossier? | 00:33:09 | |||
If you have developed a Software and you discover that it is considered a Medical Device, then what to do? Or your Software is inside a Medical Device so is this different than normal Medical Devices? In this episode with Anindya Mookerjea from Scube-technologies, we will explain to you the step that you need to follow to create a Design Dossier for your product. This is an important step as this is required for certification by the authorities. So let’s dig into it. Who is Anindya Mookerjea? Anindya is the founder and CEO of S-Cube Technologies. He has over 20 years of experience in the medical device & Software industry. Experienced in taking medical device concepts through design & development, regulatory submission, and to market. Expert in the design, development, and implementation of FDA/ISO compliant quality management systems for Medical devices & Software medical devices. Industry expert in Agile methodology implementation for Software medical devices. Strong background in testing Software medical devices. The brainchild of SmartEye product. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 06 Sep 2022 | Medical Device News - September 2022 Regulatory Update | 00:34:34 | |||
Here are the links to the Regulatory Updates HOT TOPIC
ROW
TRAINING
NOTIFIED BODIES
GUIDANCES
EASY MEDICAL DEVICE PODCAST
| |||||
| 13 Sep 2022 | Why do you need an Initial Importer for the US Market? | 00:27:26 | |||
You get a call from the US Customer border which are telling you that your products are blocked. Why that? Maybe because you have no importer defined for these products. And this is what we will explain to you today on this podcast episode. Stéphen Toupin from Dawa Medical is helping those manufacturers by being their Initial Importer and he will tell you what you should do to remain compliant. Who is Stéphen Toupin? Over the last 27 years, Stéphan has gained a wealth of experience in the Medtech and pharmaceutical industries with Astra Zeneca, Biovail, and Novo Nordisk. Stephan founded Dawa Medical in 2015 to collaborate with foreign MedTech manufacturers to enter and succeed in the massive US market. Dawa Medical is a United States Initial Importer and FDA agent, with warehousing and distribution capabilities. Dawa Medical also offers services for the Canadian and Latin American markets. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 20 Sep 2022 | How to become the best PRRC ever? [Ronald Boumans] | 00:39:17 | |||
Becoming the best PRRC ever is something that all PRRC should go for. The PRRC role is really important to avoid some situations that happened like the PIP scandal or recently the Philips issue. PRRC means Person Responsible for Regulatory Compliance and this is a mandatory role within the Medical Device industry. So if you still have no PRRC within your company then this can be a problem. So learn more about it. Ronald Boumans will help us understand what should we do to become the best PRRC ever. Who is Ronald Boumans? Ronald Boumans has seen the medical devices field from almost every corner thinkable (R&D, distribution, research, certification, standard development, market surveillance, policy making, stakeholders representation, and consulting), so he can approach most challenges from multiple angles. This helps the organizations he works with to adapt their approach to their challenges and keep full control over their processes. The ability of thinking out of the box is a precious added value in the field of regulatory compliance. Graduated as an engineer in industrial design at the Technical University of Delft in 1986, Ronald started his career in R&D for medical devices (including package design). He then moved to importing and distributing devices in The Netherlands, followed by quality research and rearch into the relation between medical devices and quality of life. This brought him to work for the Dutch competent authority as a senior inspector for medical technology. In 2013 he became a senior regulatory consultant at Emergo. In 2022 he started his own consulting company. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 27 Sep 2022 | How to select your Notified Body and understand the full process? | 00:33:12 | |||
The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects. There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions. To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 04 Oct 2022 | EPISODE 200 Celebration - Feedback from EMD Stakeholders | 00:40:46 | |||
This week, we reached 200 episodes of the Podcast and I asked some of the stakeholders to share feedback on how this helped them achieve their objectives. I also asked some of my team members to tell me what their journey was since they are part of the team. So today, this is the result of the feedback and I also wanted to thank all the listeners as this journey would not have been achieved without you. Thanks for your comments, and your nice messages. So let’s meet who is behind Easy Medical Device as I am not alone. Links
Social Media to follow
| |||||
| 11 Oct 2022 | Medical Device News - October 2022 Regulatory Update | 00:42:41 | |||
Here is your Regulatory update. Don’t forget to check the show notes for all the links we will mention on this video. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company are also acting as Authorized Representative for EU, UK and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video
| |||||
| 18 Oct 2022 | How to be MDSAP certified for your Medical Device? | 00:29:29 | |||
Within this episode, I will explain to you how you can be MDSAP certified for your Medical Devices. The agenda for this episode is the following:
Don’t hesitate to check the links below to find more resources to help you. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and notably Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of Medical Device Regulations all over the world. He has now built the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 25 Oct 2022 | Can a PRRC go to Jail? [Elem Ayne] | 00:29:11 | |||
We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team-PRRC conference and what will be talked about during that event. Join us if you are in the region. Who is Elem Ayne? Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of the “DM Experts” network (in France). She started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization. She has finally specialized in Regulatory affairs working especially in Class I reusable granted a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745. She is also the President of the Non-for-profit association Team-PRRC Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 01 Nov 2022 | Medical Device News - November 2022 Regulatory Update | 00:31:32 | |||
This month we will have some updates on:
Enjoy! Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 08 Nov 2022 | Your Software/IVD clinical report is completely WRONG! | 00:26:10 | |||
In this episode, Cesare Magri from 4BetterDevices will explain to us why medical device manufacturers are making mistakes when they try to gather Clinical Evidence for their Software or IVD devices. You may have made also this mistake and it would be better to know that before your Notified Body rejects your application. You will understand how to solve that and get some advice from Cesare. Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video
| |||||
| 15 Nov 2022 | Regulatory Pathway: How to reach the US market [Class II 510k exempt] | 00:33:47 | |||
You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: - Why the US market and not the EU? - What was the interaction with consultants for the Quality and Regulatory aspects? - How is it to work with a Quality Management System? - How is the logistic of the product working? - Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey. Who is Dr.Soumyadip Rakshit? Dr. Soum Rakshit is the Co-Founder & CEO of award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defence electronics by age 26, and has won 20+ International design awards for his product designs. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video
| |||||
| 22 Nov 2022 | Why Risk Management is important to Medical Device development? | 00:20:51 | |||
Risk Management is a discipline of its own within the Medical Device field. In ISO 13485, EU MDR 2017/745, IVDR 2017/746, FDA QSR, MDSAP… All of them talk about Risk Management. You should manage your risks. But why is this so important or even critical? This is what we will discuss with Kailash Kalidoss who is a Medical Device Engineer and also a NASA Ambassador. He will share with us his experience. PS: if your company needs an EU, UK or Swiss Authorized representative or Importer, don’t hesitate to contact Easy Medical Device. See the link below. Who is Kailash Kalidoss? The foundation of my professional experience is in consulting for complex MedTech projects, from conceptualization to product release. In my 13+ years of experience, I have worked as a Design control consultant for various leading US-based Medical Device Companies. I’m also certified by AAMI for Medical Quality System Regulations. Currently, I work for a cutting-edge engineering consulting firm based out of the Bay area in California. Academically my career is well rounded with an MBA from a prestigious B-School. Also, I have good exposure to STEM fields through MS and Engineering Bachelor degrees earlier, to effectively complement the B-School erudition. SPECIALITIES: Medical Device Design Control, Verification, and Validation, Software in Medical Devices and SaMD, Quality, Medical Device Regulations BEYOND WORK: Aerospace Educator for Civil Air Patrol, a United States Airforce Auxiliary. NASA Solar System Ambassador. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 29 Nov 2022 | How to choose the best Sterilisation Method for Medical Devices? | 00:39:21 | |||
Sterilization for medical devices is a critical topic. Now when you are developing your Medical Device, you should start by asking which sterilization process you should follow for your devices because this will lead to the question of which material you should use to build your device… So to help us have a clear understanding of how Sterilization should be defined for your medical devices, I have invited Jane Scally from Trinzo. Who is Jane Scally? Jane has supported medical device manufacturers around the world in the areas of quality management systems, remediation, strategic growth and planning, M&A due diligence and integration management, MDR transition, biocompatibility, and sterilization. Jane has Notified Body experience, performing QMS site audits in tandem with technical documentation reviews. These activities supported manufacturers maintaining their certification under the Directives and those transitioning to MDR 2017/745. Jane holds a Bachelor of Science in Applied Biology and Biopharmaceutical Science, a Higher Diploma in Pharmaceutical Business, and a Master of Science in Medical Technology Regulatory Affairs. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 06 Dec 2022 | Medical Device News - December 2022 | 00:33:19 | |||
HOT TOPICS Europe
Rest of the world
If you look for an Authorized Representative or Importer in the European area, contact us at EO@easymedicaldevice.com PODCASTS
| |||||
| 13 Dec 2022 | MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC | 00:39:31 | |||
Imagine that you have a question to ask the EU Commission, your Notified Body, or any association about being a PRRC. Then this is the episode to listen to. During the Team-PRRC event on November 3 and 4 2022, I was able to record some of the sessions and propose them to you know. Here are the people that were on the panel:
And here are the questions answered:
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Link
| |||||
| 20 Dec 2022 | EU MDR proposal for extension - Full story with Erik Vollebregt | 00:51:42 | |||
On December 9th, 2022, the EU Commission made a proposal to extend the transition period of the EU MDR 2017/745. But some people think this is already done which is not the case. There was also at the exact moment the publication of the MDCG 2022-18 on Article 97 used to continue placing devices on the market. To clarify all that I have invited Erik Vollebregt from Axon Lawyers to help us understand the situation. Many things were said, so let's now debunk all the rumors and provide you with some clear understanding. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video
| |||||
| 27 Dec 2022 | Grow your LinkedIn Profile with Karandeep Badwal | 00:45:19 | |||
Getting some visibility is the key to growing your LinkedIn Profile. And on this episode, we tell you how to be more visible or help build a community. As always you cannot do that alone so we propose you a challenge at the end. Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 03 Jan 2023 | Medical Device News: January 2023 Regulatory Update | 00:29:28 | |||
EU MDR extension
Implementing rolling plan
Borderline manual
Team NB
Notified Bodies appointed
UK Approved bodies
Training to attend and Books to read
MDCG 2022-17
MDCG 2022-18
MDCG 2022-19 and 20
MDCG 2022-21
Switzerland Annex XVI products
US Product Codes
SFDA Classification
PODCAST nostalgia
| |||||
| 10 Jan 2023 | How to improve the relationship between QA – RA and Marketing? | 00:42:18 | |||
In the Medical Device world, you need to work as a team. Sometimes it is really difficult and we will discuss that with Omar M. Khateeb. The relationship between Marketing and QA RA is one of those examples. One is willing to sell creatively and the other is trying to avoid any legal issues. So how should this be balanced? Don’t miss this episode to learn more about how you should interact with other team members within your industry. Who is Omar M. Khateeb? Omar is a MedTech marketing and sales professional who founded Khateeb & Co which helps MedTech companies grow their sales pipeline and drive product adoption at scale using social media. Having spent over a decade in disruptive technology ranging from robotics and AI to software, Omar uses his skills around persuasion, technology adoption, and category design to help companies get traction in the market. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 17 Jan 2023 | Breaking News: EU MDR Extension Proposal is out for consultation | 00:39:20 | |||
Finally, a proposal is now available, and we wanted to discuss it and identify if there are any surprises. Erik Vollebregt from Axon Lawyer is helping us understand all this. This proposal is also under consultation until January 18th, 2023. So don’t miss that as this is tomorrow for those seeing the episode today. To conclude, this is only a proposal, so this is not approved. We are still waiting for the vote. Without this vote nothing is real. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and the protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical device-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 24 Jan 2023 | How to evaluate Benefit-Risk Ratio for Medical Devices? | 00:43:59 | |||
The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant. So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio. Who is Naveen Agarwal? Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links:
| |||||
| 31 Jan 2023 | How to do Post-Marketing Surveillance in the US (vs EU)? | ||||
We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different. For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let's review that together. Who is Robert Packard? I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, I was a lead auditor and instructor for BSI - one of the largest Notified Bodies for CE Marking and MDSAP Certification. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links
| |||||
| 07 Feb 2023 | Medical Device News - February 2023 Regulatory Update | 00:25:49 | |||
Here is your Regulatory Update for the month of February 2023. Check all the links below – EU amendment of the EU MDR and IVDR: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en – EU Coverage of MDR code: https://health.ec.europa.eu/latest-updates/update-coverage-designation-codes-mdrivdr-notified-bodies-january-2023-2023-01-13_en – EU list of Standard Fees for Notified Bodies: https://health.ec.europa.eu/latest-updates/mdcg-2023-2-list-standard-fees-january-2023-2023-01-12_en – EU Delegated directive for exemption for lead as a thermal stabilizer in Polyvinyl Chloride used as base material in sensors used in in-vitro diagnostic medical devices: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13594-Electrical-equipment-lead-in-polyvinyl-chloride-for-sensors-used-in-diagnostic-medical-devices-RoHS-exemption-_en – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of EU MDR and IVDR: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf – Annual overview of devices subject to the clinical Evaluation Consultation Procedure (CECP): https://health.ec.europa.eu/latest-updates/annual-overview-devices-subject-clinical-evaluation-consultation-procedure-cecp-april-2021-june-2022-2023-01-23_en – Training EU MDR 2017/745: https://school.easymedicaldevice.com/course/gb24 – UK government response to the consultation on Medical Device Regulation: https://www.gov.uk/government/publications/government-response-to-the-rhc-report-on-medical-devices – UK MHRA increases UK assessment capacity for In-Vitro diagnostic devices: https://www.gov.uk/government/news/mhra-increases-uk-assessment-capacity-for-in-vitro-diagnostic-devices – Swiss – FAQ on Medical Devices: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_009d_mb_faq_mep_notifikationen.pdf.download.pdf/BW630_30_009e_MB_FAQ_Notifications.pdf – Notified Bodies SLG Prüf und Zertifisierungs – 37 – EU MDR https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=321000&version_no=11 https://www.slg.de.com/home.html - EU IVDR : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 – Saudi Arabia: Guidance AI/ML Software based: https://www.sfda.gov.sa/sites/default/files/2023-01/MDS-G010ML.pdf – Leading Voices in Medtech: https://lnkd.in/eUJcAQxE https://www.linkedin.com/posts/melazzouzi_medtech-easymedicaldevice-medicaldevices-activity-7025727213714997248-plJX?utm_source=share&utm_medium=member_desktop | |||||
| 14 Feb 2023 | Biological Evaluation: Top Big mistakes | 00:54:05 | |||
In this podcast episode, Laura and Paul will share with us the big mistakes done by some Medical Device manufacturers when they are considering Biological Evaluation for their products. You may need to take some notes as Laura and Paul are really knowledgeable on this process as they are onboarding some of their customers at ICARE Group and they will share with us the good, Bad and ugly. Don’t forget also to check their webpage to see what Icare can provide to you as a service. Who is Paul Fernandez? Holder of a Master’s degree in Toxicology and after a brief training in nutrition research, he began his career in regulatory affairs specialized in medical devices at ICARE when the MDR came into force. Curious by nature, and specialized in biocompatibility testing and in biological/toxicological risk analysis, he accompanies and guides many MD manufacturers in their biological evaluation strategy and after audit with authorities. He is currently Referent for the biological and toxicological safety of MD within Groupe ICARE. Who is Laura Fouzari? Following a master degree in toxicokinetics and toxicology, LF has specialized in the medical device sector and has started working on these themes for 4 years. Nowadays, she is working as a safety and toxicological safety assessor in the Regulatory Affairs Unit within the Biotox Unit of Groupe Icare. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links:
| |||||
| 21 Feb 2023 | SaMD international reach – What to consider? | 00:35:07 | |||
We are in a global world, so normally what is good for the EU can be also good for other countries. But here the only barrier is local law. This is mainly what we will discuss on this Podcast. We will use the example of SaMD or Software as a Medical device for it and share with you the experience that we have but this is applicable to nearly all medical devices. Check the podcast page at: https://podcast.easymedicaldevice.com/220-2/ ——————————————————————————————————- ► Who is Stéphane Berger? Holder of a diploma in Electronics, with an experience of 25 years in the industry, after 10 years in the semiconductor field service business, he entered the medical device world in an ultrasound imaging company and started to implement ISO13485 requirements as customer service director and operation director. He began his career in quality and regulatory affairs in a recognized Notified Body with a position of auditor specialized in medical devices and software. He is currently holding the position of Regulatory and Quality Affairs Manager at Avicenna.AI, a French start-up that provides artificial intelligence solutions for radiology. Their products are registered in more than 40 countries worldwide and follow the evolving world of regulation around the Artificial Intelligence and Medical Device markets. ——————————————————————————————————- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. ——————————————————————————————– ► Links from the Video ■ LinkedIn Profile of Stéphane Berger: https://www.linkedin.com/in/bergerstephane ■ Avicenna Website: https://avicenna.ai/ ■ WHO listing of Worldwide requirements: https://apps.who.int/iris/rest/bitstreams/1480622/retrieve ■ Authorized Representative Service: https://easymedicaldevice.com/authorised-representative-and-importer/ ——————————————————————————————- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ———————————————– #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 28 Feb 2023 | Principal at Test labs | 00:32:04 | |||
The EU MDR is planning to be really challenging for Class I reusable Surgical Instruments as they will need to move to Class Ir. In this Episode Tautvydas from Test Labs will explain to us what is expected from the Medical Device Manufacturers. What they should prepare for being compliant to the new regulation. ——————————————————————————————————- ► Who is Tautvydas Karitonas? Tautvydas is focused on accelerating access to market for medical devices. He has almost a decade of experience developing state of the art products for healthcare, which are now used in hospitals worldwide. Tautvydas provides expertise in product development, validation and problem solving. ——————————————————————————————————- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. ——————————————————————————————– ► Links from the Video ■ LinkedIn profile Tautvydas: https://www.linkedin.com/in/tautvydaskaritonas/ ■ Test Labs webpage: www.testlabsuk.com ■ MDCG 2020-2 – Class I transition: https://health.ec.europa.eu/document/download/e87d08dc-87ab-49d9-8ffa-5552fa978d14_en ■ Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/ ——————————————————————————————- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice —————————————————————————————— #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 08 Mar 2023 | Medical Device News: March 2023 Regulatory Update | 00:40:20 | |||
Here is your Regulatory Update for the month of March 2023. Check all the links below - EU MDR 2017/745 extension has been voted: https://www.raps.org/news-and-articles/news-articles/2023/2/europeanparliament-votes-to-extend-mdr-transition -UK Impact of extension of Medical Device Regulations transitional period and the validity of Certificated in the EU: https://www.gov.uk/government/news/impact-of-extension-of-medical-device-regulations-transitional-period-and-thevalidity-of-certificates-in-the-eu -Ireland - Article 97 request form : https://www.hpra.ie/homepage/about-us/publications-forms/forms-applications/item id=e4cb1326-9782-6eee-9b55-ff00008c97d0 -EU Team-NB. Best practice Guidance for the submission of Technical Documentation for IVDR: https://www.teamnb.org/team-nb-pp-best-practice-guidance-for-the-submission-of-technical-documentation-under-annex-ii-and-iii-of-in-vitrodiagnostic-medical-devices-regulation/ -EU Team-NB . IVDR technical Documentation training for manufacturers: Wednesday June 14th, 2023 https://www.teamnb.org/wp-content/uploads/members/M2023/Leaflet-IVD-TC-Manufacturers-Training- -EMA pilots scientific advice for certain High-Risk Medical Devices: https://www.ema.europa.eu/en/news/ema-pilotsscientific-advice-certain-high-risk-medical-devices - New Notified Bodies ○ NSAI for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321463&version_no=10 ○ MDC for IVDR: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id= 321397&version_no=8 -Spain AEMPS: Notice addressed to Notified Bodies and Manufacturers of Nasal Sprays with Virucidal or Microbicidal action: https://www.aemps.gob.es/informa/la-aemps-publica-una-nota-de-aviso-dirigida-a-organismos-notificados-y-a-fabricantesde-esprais-nasales-con-accion-viricida-o-microbicida/ -Swiss - Q&A for IVD notification: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_30_010d_mb_faq_invitro_diagnostika_meldungen.pdf.download.pdf/BW630_30_010e_MB_FAQ_Notifikationen_IVD.pdf /search-fdaguidance-documents/guidance-industry-and-food-and-drug-administration-staff-assemblers-guide-diagnostic-xray-equipment -Performance standard for Diagnostic X-Ray systems. https://www.fda.gov/regulatory-information/search-fdaguidance-documents/performance-standard-diagnostic-x-ray-systems-and-their-majorcomponents-21cfr-102030-102031-102032 -Medical X-ray imaging devices coformance with IEC Standards: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-x-ray-imaging-devices-conformance-iec-standards -List of cleared Companion Diagnostic: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-orapproved-companion-diagnostic-devices-in-vitro-and-imaging-tools -US Medsun February 2023: https://www.fda.gov/media/165125/download -SAUDI-DI Webinar March 20th 2023 https://www.sfda.gov.sa/en/workshop/87814 -Link to Webex: https://zoom.us/j/95729656046?pwd=NmNOLzZYT0hmK3JqVXhPQ25LQmQ5Zz09 -Link to Webex: https://zoom.us/j/93572022832?pwd=K1ZVL2xTNXFHV3NEdXVGbk4yN0Z3Zz09 -South Africa. SAPHRA Q&A on Licensing of Medical Device establishment: https://www.sahpra.org.za/wpcontent/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device- Establishments.pdf ○ Episode 219 - Biological Evaluation: Top Big Mistakes (Paul Fernandes and Laura Fouzari) https://podcast.easymedicaldevice.com/219-2/ ○ Episode 220 - SaMD International Reach (Stephane Berger) https://podcast.easymedicaldevice.com/220-2/ ○ Episode 221 - Prepare your transition from Class I to Class Ir https://podcast.easymedicaldevice.com/221-2/ ○ LinkedIn Live - Samd Class I - To be published this week ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 14 Mar 2023 | What you should know about Vigilance Reporting? | 00:37:45 | |||
Vigilance Reporting is a process that you should have but that you don’t want to us. In fact not having any vigilance reporting is a sign that you product is doing well. But having one means that maybe you need to improve your device. ------------------------------------------------------------------------------------------------------- ► Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. ------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. ------------------------------------------------------------------------------------------------------- Links: LinkedIn profile Adam Isaacs Rae: https://www.linkedin.com/in/adam-isaacs-rae/ Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/ ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedical... ■ Instagram: https://www.instagram.com/easymedical... ------------------------------------------------------------------------------------------ #medtech #medicaldevice #compliance | |||||
| 21 Mar 2023 | Proactive Postmarketing Surveillance. What does it mean? | 00:44:36 | |||
The EU MDR is requiring more transparency and for the PMS has a lot to play on it. In this episode we will explain to you a difference that is visible for PMS which is the Proactive Postmarketing Surveillance. We will explain what they mean by that and how some digital tools can help you. ► Who is Marcus Emne? Marcus Emne is the CEO & founder of Hoodin, the intelligence SaaS for life science & compliance. Marcus has extensive experience in international business from both high tech, software and life sciences. Over the last years, he has had a focus on intelligence and the subdomains Ai, Automation and Machine Learning in relation to regulatory needs within life science. If you wish to get further guidance or discuss RA/QA in relation to Ai, Automations and Machine Learning, feel free to contact Marcus. ----------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video ■Schedule a discovery call: https://rb.gy/nl9ghd ■email: marcus@hoodin.com ■LinkedIn: https://www.linkedin.com/in/marcusemne/ ■LinkedIn profile Marcus Emne: https://www.linkedin.com/in/marcusemne/ ■Hoodin web page: https://www.hoodin.com/ ■Schedule a discovery call: https://rb.gy/nl9ghd ■MDCG PMS 2022-21 https://health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf ■Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/ ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance
| |||||
| 28 Mar 2023 | How to perform Risk Management for a Software ? | ||||
In this episode, Bijan Elahi will help us perform risk management for SaMD and give us some tips on the best strategies. Bijan is also the author of the book “Safety Risk Management for Medical Devices”. If you have to perform risk management for a software as a Medical Device or Medical Device software you may think how this can be done?, Are the tools, standards, the same as for normal medical devices? Are the risks different? Bijan Elahi will be my guest on this episode and will explain to us the best practices for SaMD risk management. Don’t miss this and also his book called “Safety Risk Management for Medical Devices”. Link below. ----------------------------------------------------------------------------------------------------------------------- ►Who is Bijan Elahi? Bijan Elahi has worked in safety risk management for medical devices for over 25 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry in the early 1990’s. Bijan is the corporate expert on risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Delft University of Technology, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the book Safety Risk Management for Medical Devices. ----------------------------------------------------------------------------------------------------------------------- ►Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. ----------------------------------------------------------------------------------------------------------------------- Link: - Bijan Elahi LinkedIn Profile:https://www.linkedin.com/in/bijanelahi/ - Book: “Safety Risk Management for Medical Devices” - Episode 207: Why Risk Management is important to Medical Device development:
- Episode 216: How to evaluate Benefit-Risk ratio for Medical Devices?:
- Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/ ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 04 Apr 2023 | Medical Device news for April 2023 | 00:27:38 | |||
► Podcast page: https://podcast.easymedicaldevice.com/226-2/ ► Medboard platform: https://www.medboard.com/ ► MEDBOARD SHOW NOTES LINKS: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/ Today on this Medical Device news for april 2023 we’ll talk about • The EU MDR Extension vote https: //health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a.pdf • The Notified Bodies that are certified https: //www.team-nb.org/frequency-of-complete-re-assessments-of-notified-bodies/ • The changes in EU spain, UK, Switzerland, Belgium https: //www.sfda.gov.sa/sites/default/files/2023-03/MDS-G012A.pdf • But also Middle East, USA, Brazil. https: //www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/consumidor-ganha-plataforma-para-notificacao-de-eventos-adversos --------------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video -MEDBOARD SHOW NOTES LINKS:: https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/ - Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 11 Apr 2023 | What is a SOUP for your Software Development | ||||
in this context SOUP is not a dish but Software Of Unknown Provenance which is the term used for Software that was not created by you. Christian Kaestner from Medical Device HQ will explain to us what you should consider when you have a SOUP within your product. SOUP is the acronym for Software Of Unknown Provenance. This is mainly a piece of software that you want to use on your Medical Device but that you have not developed yourself. So if you have such thing, then you need to listen to this podcast episode with Christian Kaestner from Medical Device HQ. ►Who is Christian Kaestner? Christian Kaestner is a highly skilled professional with over 25 years of experience in the medical device field. As a software developer with a deep interest in medical device software, Christian has the technical background to understand software development. Christian was on the project teams that authored IEC 62304 and IEC 82304-1, so he has in-depth experience working with standards. If you're looking to improve your team's knowledge and skills, Christian offers online courses through Medical Device HQ to keep you up-to-date with industry best practices. He can also guide you in setting up your development process to comply with relevant standards. Visit medicaldevicehq.com to learn more, and feel free to connect on LinkedIn. ----------------------------------------------------------------------------------------------------------------------- ► Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video ■LinkedIn: https://www.linkedin.com/in/christiankaestner/ I’m happy to answer short follow-up questions through LinkedIn messages. ■Blog post on how to manage SOUPs: https://medicaldevicehq.com/articles/managing-and-documenting-soup-and-ots-in-medical-device-software/ ■Medical device resources on YouTube: https://www.youtube.com/medicaldeviceHQ Playlist with medical device software videos on YouTube:
------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance | |||||
| 18 Apr 2023 | Prepare your audit like a PRO | 00:40:55 | |||
If you are selling a Medical Device that is not a class I, then you know that you have to go through an audit with a Notified Body. So let’s discuss how you should be prepared for that with Karandeep Badwal. An Audit is really an exercise that all Quality and Regulatory people should understand to master it. See it as a performance on stage, or a sport competition. Before it happens, you should prepare yourself. We will discuss on this episode with Karandeep Badwal of the way that you should be preparing and the tips and tricks that you will need to know. Internal audit, CE audi, ISO audit, MDSAP audit, Supplier audit … You’ll have to go through this within many occasions so be ready for it. Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/ Easy Medical Device blog on audit: https://easymedicaldevice.com/internal-audit/ Podcast episode on audit: https://podcast.easymedicaldevice.com/175/ Video on internal audit: https://www.youtube.com/watch?v=UA_J_WXLPag&pp=ygUiZWFzeSBtZWRpY2FsIGRldmljZSBpbnRlcm5hbCBhdWRpdA%3D%3D Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 25 Apr 2023 | Transition to Agile for Software as Medical Device | 00:36:00 | |||
We start to talk more and more of Software as Medical Device or SaMD. This time we will check with you how to develop a Software and transition to the Agile methodology with the company IronRooster. Waterfall? Agile? … The methodology to develop a Software are multiple but you need as a company to define it prior to the project so you have the right pathway to follow. And in this episode of the podcast we will help you transition to the AGILE methodology for Software development. This is a well known method but we’ll try also to explain its advantages and also look at the way for you to transition to it. Bence and Attila from IronRooster will be my guests and they will tell you the tips an tricks about Agile development Who is Bence Török? I am Bence, a proud member of the Iron Rooster team for two years now, spending most of my time trying to improve a MedTech project. I began my journey in the IT field as a technical writer working on Telecommunication projects, but after joining Iron Rooster, I quickly realized that project management was where I wanted to focus. Therefore, I delved into it and continue to expand my knowledge each day. Currently, I manage several MedTech projects and work with excellent software professionals in the blood banking industry, where we cover everything from donor recruiting to laboratory testing. Who is Attila Katona? My name is Attila, and I am a senior member of the Iron Rooster team. I have been a long-time (tor)mentor for my merry team of quality assurance and regulatory compliance experts in our medical software development company. Over the years, I have been involved in 50+ projects in half a dozen different roles, performing various roles ranging from requirements engineering and test management to designing complex product documentation processes and full QMS maintenance. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video IronRooster Linkedin page: https://www.linkedin.com/company/ironrooster/ Bence Linkedin Page: Attila Linkedin Page: IronRooster website: https://ironrooster.io/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 05 May 2023 | Medical Device news - May 2023 Regulatory Update | 00:28:29 | |||
•Team-NB Sector Survey 2022 :https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-MD-Sector-Survey-PressRelease-20230411.pdf • MDCG planning available :https://health.ec.europa.eu/system/files/2023-04/md_events_2023_en_1.pdf •TEAM-NB position paper : https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf •Finland - Electronic Submission for Medical Devices :https://www.fimea.fi/web/en/-/electronic-submissions-for-medical-devices-will-be-opened-on-2-may-2023 •France- Digital Medical Application reimbursement :https://esante.gouv.fr/espace-presse/lancement-de-la-prise-en-charge-anticipee-des-dispositifs-medicaux-numeriques • Switzerland - IVD performance studies : https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw600_00_016e_mb_performance_studies_with_ivd.pdf.download.pdf/BW600_00_016e_MB_Information_performance_studies_IVD_KlinVMEP.pdf •Switzerland – IMDRF OFFICIAL OBSERVER :https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/swissmedic-official-observer-imdrf.html • UK - Transition from CE to UKCA :https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations • Training EU MDR :https://school.easymedicaldevice.com/course/gb25 USA: Draft guidance on PCCP for AI/ML :https://www.fda.gov/media/166704/download o USA: Radiation Sterilization Master File Pilot Program :https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-radiation-sterilization-master-file-pilot-program. o Australia: Regulation for software based medical devices :https://www.tga.gov.au/how-we-regulate/manufacturing/medical-devices/manufacturer-guidance-specific-types-medical-devices/regulation-software-based-medical-devices o China: Guideline for Medical Device :https://www.cmde.org.cn/xwdt/zxyw/20230404163902154.html o India: List of Notified Bodies registered in India : o Mexico, Colombia & Cuba sign the Acapulco Declaration : https://www.gob.mx/cofepris/articulos/se-firma-declaracion-de-acapulco-para-creacion-de-la-agencia-reguladora-de-medicamentos-y-dispositivos-medicos-de-latinoamerica-y-el-caribe?idiom=es oSaudi Arabia Webinars : •May 9, 2023 Guidance on Medical Devices Classification https://www.sfda.gov.sa/en/workshop/88229 •May 22, 2023 Product Sterilization Requirements for Medical Devices https://www.sfda.gov.sa/en/workshop/88228 oPodcast Nostalgia •Episode 227: What is a SOUP for your Software Development Christian Kaestner Medical Device HQ https://podcast.easymedicaldevice.com/227-2/ •Episode 228: Prepare your Audit like a PRO with Karandeep Badwal https://podcast.easymedicaldevice.com/228-2/ •Episode 229: Transition to Agile for Software as Medical Device: https://podcast.easymedicaldevice.com/229-2/ Ask Easy Medical Device . We can help you •Contact at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 09 May 2023 | The truth about the UK vs EU situation | 00:50:30 | |||
Since Brexit, the UK market is really trying to find a way to come back to normal and extract themselve from the EU legislation. They are doing it step by step but for the moment a lot of the products we see are relying on the EU rules. But UKCA is about to be the rule. I mean we thought this will be the rule but apparently there are new timelines coming. So let’S discuss that with Claire Dyson Who is Claire Dyson? Claire Dyson is a seasoned professional in the Med Tech space having spent more than a decade in manufacturing and the last 5 years in certification bodies. She began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and became Head of UK Approved Body for DEKRA in 2022. She recently resigned and is spending some time creating accessible content to support manufacturers with the regulatory transitions being implemented across Europe. Claire has set up her own company, CAPD Consultancy Ltd, whilst building up a network to help identify the needs across the industry and provide the right type of help that manufacturers need. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, youtube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Claire Dyson Linkedin page: https://www.linkedin.com/in/claire-dyson-85845b4b/ UK transition timelines: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk UK transition rule: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations UK medical device regulation: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk UK Government’s response to the 2021 consultation outlining the future of UK medical device regulations: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_theUnited_Kingdom.pdf Social Media to follow: Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldeviceAuthorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 16 May 2023 | Technical Files Inconsistencies identified by Notified Bodies | 00:23:58 | |||
This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation... So if you want to avoid these issues don't miss this episode as they can cost you time and money. Who is Adam Isaacs Rar? Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links:
Social Media to follow
| |||||
| 23 May 2023 | What if your Medical Device company goes Bankrupt? | 00:22:24 | |||
This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We’ll try to give you some advice on how to overcome this situation. Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video
Social Media to follow
| |||||
| 30 May 2023 | How to master regulatory intelligence | 00:41:47 | |||
We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search. Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our discussion with Ivan Perez Chamorro from MedBoard. Who is Ivan Perez Chamorro? Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical. Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN. After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry. Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Ivan Perez Chamorro LinkedIn: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/ Blog post Medboard: Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 08 Jun 2023 | Medical Device News -June 2023 regulatory update | 00:30:49 | |||
Sponsor MedBoard: www.medboard.com EUROPE Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf EU MDR and IVDR consolidated versions EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320 EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320 Confirmation letter: EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054 EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262 Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/ Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices Training: Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26 Switzerland Incident reporting Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf United Kingdom New tutorial videos MHRA "How to register medical devices": https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system
ROW Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device : https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/ Saudi Arabia Webinar: Explain The Essential Principles of Safety and Performance for Medical Devices: https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450 Podcast Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/ Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/ Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/ Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/ Ask Easy Medical Device . We can help you Contact at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 13 Jun 2023 | The great misunderstanding of EU MDR amendments | 00:42:53 | |||
Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out. For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension. Who is Florian Tolkmitt? Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/ Pro-Liance company Site: https://pro-liance.com/ LinkedIn Company: https://www.linkedin.com/company/pro-liance/ Social Media to follow: Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 20 Jun 2023 | How to connect Software dev and QA RA Team | 00:31:06 | |||
Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that. Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved. Who is Christophe Girardey? Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/ Medical Device: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance Agile : https://www.wega-it.com/computer-systems-validation-quality-assurance#agility-in-gxp Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 27 Jun 2023 | What should you know on UKCA extension | 00:27:29 | |||
Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks. But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows. Don’t forget to check the links below for more details. Who is Alex Denoon? Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years. He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs. Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Alex Denoon Linkedin : https://www.linkedin.com/in/alexdenoon Bristows law firm linkedin page: https://www.linkedin.com/company/bristows/ Bristows Website : https://www.bristows.com/ Bristows Blog post on UKCA: https://www.bristows.com/news/will-we-ever-see-a-ukca-mark-for-medical-devices/#:~:text=Currently%2C%20the%20UK's%20medical%20device,conformity%20marking%2C%20the%20UKCA%20mark UKCA future implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations Infographics timeline: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk Your UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 04 Jul 2023 | Medical Device News - July 2023 Regulatory Update | 00:23:41 | |||
Sponsor Medboard https://www.medboard.com/ EU Annex XVI transition EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline Until 31 December 2029 Cybersecurity and privacy in AI Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice Why not all the other countries AEMPS clinical trials involving drugs and medical devices What are the rules if your device is not CE marked Switzerland Medicinal products with a medical device component rules for combination products UK Implementation of the Future Regulations Should you focus on UKCA? eQMS Do you need an eQMS? Let me introduce Smarteye: https://smart-eye.io So contact info@scube-technologies.com to get a demo USA Premarket notification for Software What is different with Premarket submission for hardware https://www.fda.gov/media/153781/download Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023 Australia TGA Use of market authorisation evidence Comparable overseas regulators https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds Malaysia Malaysia rules on EU MDR extension Letter needed Saudi Arabia Saudi Arabia Webinars AI and Classification are on the spotlightArtificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535 Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536
Authorized Representative Do you need an Authorized Representative info@easymedicaldevice.com Service: easymedicaldevice.com
Podcast Nostalgia: Podcast Nostalgia What was presented in June. The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/ How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/ What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/
Easy Medical Device Support Thanks for your support info@easymedicaldevice.com If you need us to perform your own Regulatory Update, don't hesitate to contact us at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particuarly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424
| |||||
| 11 Jul 2023 | How to register Medical Devices in Saudi Arabia | 00:36:25 | |||
I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for you. Who is Ahmed Hendawy? Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Ahmed Hendawy Linkedin : https://www.linkedin.com/in/ahmed-hendawy-a0a81511a Registitute LinkedIn: https://www.linkedin.com/company/registitute/ Registitute Website : www.registitute.com AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/ SFDA website : www.sfda.gov.sa SFDA Guidance for Medical Device registration: https://sfda.gov.sa/sites/default/files/2019-12/MDS-G5_1.pdf Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 18 Jul 2023 | Validation of Quality Softwares in MedDev | 00:35:16 | |||
Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software. Who is Christophe Girardey? Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links from the Video Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 25 Jul 2023 | Artificial Intelligence in the Medical Device Industry | 00:38:37 | |||
Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software. Who is Christophe Girardey? Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/ Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance Data Sciences: https://www.wega-it.com/clinical-development-it#data-science Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s Nature Article (co-authored): https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices? Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 01 Aug 2023 | Who should be on your Risk Management Dream Team? | 00:41:20 | |||
When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that. Who is Naveen Agarwal? Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/ Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt Achieve Website: https://www.achievexl.com Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424 | |||||
| 08 Aug 2023 | Hire your QA RA person with no Budget | 00:38:04 | |||
Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you in the podcast episode. Mitch Robbins is a professional recruiter that has its own agency “The Anthony Michael Group”. He is able to help you on your research as he is specialised in QA RA recruitment. But he also knows your pain when your company cannot hire a recruiter for this mission. So, we will review what he proposes to you to be successful regarding this challenge. Who is Mitch Robbins? Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Mitch Robbins Linkedin : https://www.linkedin.com/in/mitchrobbins Linkedin Post: https://www.linkedin.com/posts/mitchrobbins_regulatoryaffairs-hiring-theanthonymichaelgroup-activity-7076976156570243073-kEsY/ Podcast Med-Tech Talent Lab: https://spoti.fi/3LqqubL The Anthony Michael Group website: https://www.theanthonymichaelgroup.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 15 Aug 2023 | Why you should automate your Software validation? | 00:41:28 | |||
Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data. In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that you can automate your validation and you don’t need to test everything manually. That would save you a lot of time. But what are the benefits or pitfalls of it? Don’t miss this episode if you are in software development or if you use Software to manage quality data. Who is Christophe Girardey? Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. Who is Virginie Rochat? Virginie is leading the Test Automation team at wega, a life science consulting company specialized in digitalization. The Test Automation team is composed of people with a broad range of backgrounds - from software and testing engineers to QA and Validation specialists - in order to support Pharmaceutical and Medical Device companies when it comes to automate end-to-end testing. With its expertise in user interface test automation tools, wega can support you through the selection of the proper tool based on your needs and infrastructure, validate the tool and then help your teams into the development of automated test cases and provide the necessary experience to support your team to reach compliance in a more efficient way. Virginie has more than 10 years of experience within pharma laboratories. She has always been keen to automate repetitive tasks and prone to adopt new technologies to improve the efficiency of the business processes, leading her to develop more and more knowledge on informatic and technologies, to bridge the gap between Science and IT. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Article on Test Automation: https://www.wega-it.com/en/automatisierung-von-softwaretests-fuer-nutzeranforderungenChristophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Virginie Rochat Linkedin: https://www.linkedin.com/in/virginie-rochat86/ wega Website : https://www.wega-it.com/ Medical Device: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 22 Aug 2023 | What are the Acceptance Criteria for your Clinical Evaluation? | 00:33:11 | |||
We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the crosses. Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: -Cesare Magri Linkedin : https://www.linkedin.com/in/cesare-magri/ 4BetterDevices -LinkedIn Page: https://www.linkedin.com/company/4betterdevices/ -Website 4BetterDevices: https://4betterdevices.com/ Social Media to follow -Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi -Twitter: https://twitter.com/elazzouzim -Pinterest: https://www.pinterest.com/easymedicaldevice -Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 29 Aug 2023 | How to perform your Cleaning Validation in practice? | 00:38:42 | |||
Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues… So let’s listen to Enrico Allegra from TestLabs who will share with us his experience. Who is Enrico Allegra? Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings. He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women. He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist. The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models. The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients. He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links from the Video ■Enrico Allegra LinkedIn: https://www.linkedin.com/in/enrico-allegra-b97751164 ■TestLabs LinkedIn Page: https://www.linkedin.com/company/testlabsuk/ ■TestLabs webpage: https://testlabsuk.com/ Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 06 Sep 2023 | MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update | ||||
EU o MDR and IVDR communication Survey • EU MDR transition • Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf • Flowchart to decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf o Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf • Blog Post - Erik Vollebregt . Can we fix/improve the MDR and the IVDR? : https://medicaldeviceslegal.com/2023/08/29/can-we-fix-improve-the-mdr-and-the-ivdr/
• Team-NB: Transfer agreement :https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-TransferAgreement-V1-20230811.pdf • Notified Bodies situation :https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf • EMA consultation: https://www.ema.europa.eu/en/documents/other/questions-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary_en.pdf Training offered: • Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ •Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/ • Green Belt: https://school.easymedicaldevice.com/course/gb26/ UK: o CE Marking recognition: https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=70128116-5d7a-4e60-89d6-99e578f8a33b&utm_content=immediately • Ronald Boumans article: https://www.linkedin.com/posts/ronald-boumans_ukca-maring-for-medical-devices-and-ivds-activity-7092405961541185536-bfRY?utm_source=share&utm_medium=member_desktop • Guardian article: https://www.theguardian.com/commentisfree/2023/aug/04/business-brexit-safety-mark-red-tape-?mibextid=Zxz2cZ • Guardian article: https://www.theguardian.com/politics/2023/aug/08/left-in-limbo-by-brexit-safety-mark-chaos?mibextid=Zxz2cZ
o 3 new UK Approved bodies :https://www.gov.uk/government/news/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra • Approved Body list: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies
TGA: Webinar : The new Medical devices Vigilance Program- Information for medical device Sponsors in
Canada: o Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html USA: o Off-the-Shelf Software :https://www.fda.gov/media/71794/downloadSaudi Arabia: o ISO 13485 for manufacturers & supplies facilities : https://www.sfda.gov.sa/sites/default/files/2023-08/MD-Quality13485.pdf eQMS: o SmartEye : https://smart-eye.io Conferences o MEDXD - Berlin Germany September 26 and 27- : https://medtechx.digital/ • Afrisummit - Cairo Egypt : https://www.pharmaregafrisummit.com/meddev/ • MEDICA - Dusseldorf Germany : https://www.medica-tradefair.com/ • Team-PRRC - Strasbourg France : https://www.team-prrc.eu/page/1111392-presentation Podcast to listen : • Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/ • The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3 • The Med-Tech Talent Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OPbgsS6DqhCZuAFG2• Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900 • State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6 Podcast Nostalgia • Who should be on your Risk Management Dream Team with Naveen Agarwal: https://podcast.easymedicaldevice.com/243-2/ • Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com/244-2/ • Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com/245-2/ • What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com/246-2/ • How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com/247-2/ | |||||
| 13 Sep 2023 | Interviews on Being The PRRC | 00:47:02 | |||
Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different economic operators The second one with Erik Vollebregt where we will review the role of a PRRC and liability The third one with Ronald Boumans where we will explain how to behave to be a PRRC And the last one with Christopher Kipp from BVMed on the PRRC role in Germany with the already existing safety officer. Don’t miss the next Team-PRRC event November 16-17 2023 in Strasbourg. Links Piero Costa LinkedIn Page: https://www.linkedin.com/in/pierocosta1980 Erik Vollebregt LinkedIn Page: https://www.linkedin.com/in/erikvollebregt/ Ronald Boumans LinkedIn Page: https://www.linkedin.com/in/ronald-boumans/ Christopher Kipp Linkedin Page: https://www.linkedin.com/in/christopher-kipp-b16ba71b1/ Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 19 Sep 2023 | Interviews on Being The PRRC | 00:21:52 | |||
In this second part of this podcast serie on Team-Prrc interviews. we have 3 additional guests. Don't miss the first one where we also got great interviews. In this episode, we will interview - Bassil Akra about the Team-PRRC event and why you should come. This will happen again November 16th and 17th. - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company - Elem Ayne, the Team-PRRC presidente who will explain to us more about the event and how this first session went. So don't miss the next opportunity to meet everyone at the Team-PRRC event in Strasbourg - France on November 16th and 17th. You'll be able to create a great network. Links from the Video Bassil Akra Linkedin: https://www.linkedin.com/in/bassil-akra-akrateam/ Elena Kyria Linkedin: https://www.linkedin.com/in/elenakyria/ Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne/ Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 26 Sep 2023 | What is the EUDAMED Update? | 00:32:37 | |||
EUDAMED is the European Database for Medical Devices. In this episode Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 asks you to register your company, your products in this database. Who is Richard Houlihan? Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions. His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.
Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Link: Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/ EUDAMED.Com website: https://eudamed.com/ EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/ EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html Playground: https://webgate.training.ec.europa.eu/eudamed-play Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 04 Oct 2023 | MEDICAL DEVICE NEWS October 2023 Regulatory Update | 00:34:15 | |||
EU Manual on Borderline and classification for Medical Devices Update - New entries to the file: https://health.ec.europa.eu/system/files/2023-09/md_borderline_manual_en.pdf Q&A on Annex XVI Products - Check transition timeline: https://health.ec.europa.eu/system/files/2023-09/md_new-reg_annex-xvi_q-n-a_transition-prov.pdf Italy: Custom-made medical device registration - Specific website available: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6352 Ireland: Custom-made device Webinar October 19th, 2023 - Webinar to join: https://www.hpra.ie/homepage/medical-devices/news-events/item?t=/custom-made-device-(cmd)-regulation-webinar&id=5ad21426-9782-6eee-9b55-ff00008c97d0 Team-NB - Training on MDR Technical Documentation for Manufacturers - Date of the event November 7th, 2023: https://www.team-nb.org/new-team-nb-initiative-mdr-technical-documentation-training-for-manufacturers/ Technical Documentation template Premium Pack: https://school.easymedicaldevice.com/product/eu-mdr-technical-file-premium-pack/
FIMEA designate first Notified Body under the IVD regulation in Finland - EUROFINS Electric & Electronics Finland Oy: https://www.fimea.fi/web/en/-/fimea-designates-the-first-notified-body-under-the-ivd-regulation-in-finland UK The innovation Devices Access Pathway (IDAP) - Pilot Phase to join - Answer before October 29th, 2023: https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase CH Swissdamed Survey Report - The EUDAMED for Switzerland to start in 2024: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/infos/survey-results-report.pdf.download.pdf/20230919_swissdamed_survey%20results%20report.pdf Conferences Which conferences to focus on? - I will be going to them so join me. MEDXD: Digitalisation of Medtech: https://medtechx.digital/ Afrisummit in Egypt: https://www.pharmaregafrisummit.com/ Medica: https://www.medica-tradefair.com/ Team-PRRC: https://www.team-prrc.eu/ Training Trainings for you - Self-paced Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit Readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/ US US FDA - De Novo Request - Electronic Submission template: https://www.fda.gov/media/172450/download Webinar US FDA - Cybersecurity in Medical Devices: - November 2nd 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-cybersecurity-medical-devices-quality-system-considerations-and-content Webinar US FDA - Breakthrough devices program update - November 14th, 2023: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-breakthrough-devices-program-updated-final-guidance-11142023 Digital Health FAQ - Is your medical device an SaMD?: https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-frequently-asked-questions-faqs ISO 10993-1:2018 versus FDA - FDA is adding its touch: https://www.fda.gov/media/142959/download Best practice for selecting a Predicate device for your 510K - Method provided. https://www.fda.gov/media/171838/download Saudi Arabia SFDA Significant changes guidance - Template inside: https://www.sfda.gov.sa/sites/default/files/2023-09/MDS-G12a.pdf Malaysia Malaysia: Workshop preparation of documents for Submission - October 23rd, 24th and 30th: https://www.mda.gov.my/announcement/1285-first-announcement-hands-on-workshop-efficient-way-to-prepare-for-mda-documentation-submissions.html
Turkey Mutual Recognition of Authorized rep and NB in Turkey - Good clarification: https://titck.gov.tr/duyuru/tcokka-mutual-recognition-of-authorized-representatives-and-notified-bodies-in-the-field-of-medical-devices-between-the-eu-and-turkiye-19092023160242Japan Japan: Essential Principles - In 2023 inclusion of the Cybersecurity risks: https://www.std.pmda.go.jp/stdDB/Data_en/InfData/Infetc/MHLW_Notification_122_of_2005.pdf India India: List of registered medical device testing laboratory - under Indian mdr 2017: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE= Podcast Podcast Nostalgia - Do you remember? Episode 249: Team-PRRC interviews part 1 : https://podcast.easymedicaldevice.com/249-2/ and 250: part 2: https://podcast.easymedicaldevice.com/250-2/ Episode 251: EUDAMED Updates: https://podcast.easymedicaldevice.com/251-2/ QMS How Easy Medical Device can help you -easymedicaldevice.com We can also help you implement our eQMS - Smarteye: https://smart-eye.io | |||||
| 10 Oct 2023 | What are some pitfalls to avoid during Software Design? | 00:35:46 | |||
More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid. Weronika will talk about: - Risk Management - Usability - Documentation - Expertise - Interoperability and scalability - Cybersecurity. So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions. Who is Weronika Michaluk? Weronika Michaluk is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She is a Biomedical Engineer by training, holds a Master's degree in International Business from the University of Miami, an MBA from the Warsaw School of Management, and a Doctorate in Public Health (DPH) with a specific focus on the business strategy of Agile Development of Software as a Medical Device (SaMD). Weronika's career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that she focused on digital health solutions and consulting in the medical device space. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Weronika Michaluk LinkedIn Page: https://www.linkedin.com/in/weronika-michaluk-mba-43811698/ HTD Health website: https://htdhealth.com/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 17 Oct 2023 | Afrisummit 2023 Interviews Part 1 | 00:34:52 | |||
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. First, I have the interview with Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) - Morocco. We reviewed the Quality and Regulatory situation of Morocco and learned a lot of good information about progress that the authorities are ongoing to be modernized. Second, we have the interview with Rana Chalhoub - Regulatory Affairs Director at Mecomed. We reviewed the situation in Middle East and Africa and why a summit like Afrisummit is important. Third, the interview with Dr. Mona Al Moussali - Co-founder PRA Consultancy and organizer of the Afrisummit. We reviewed how the summit went and what are some feedback out of it. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link Morad Ajan LinkedIn Page: https://www.linkedin.com/in/ajanm/ DMP website: https://dmp.sante.gov.ma/ Rana Chalhoub LinkedIn Page: https://www.linkedin.com/in/rana-chalhoub-8a391214/ Mecomed website: https://www.mecomed.com/ Dr Mona Al Moussali LinkedIn Page: https://www.linkedin.com/in/mona-almoussli/ PRA Consultancy Website: https://pra-me.com/ Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 24 Oct 2023 | Afrisummit 2023 Interviews Part 2 – Egypt Situation | 00:32:14 | |||
The Afrisummit 2023 in Egypt is over, and I came back with some interviews of some key stakeholders. This is the part 2 where we will focus on the Egypt situation. Check Part 1 for the first interviews with (https://podcast.easymedicaldevice.com/254-2/): - Morad Ajan - Head of Medical Device Unit at Direction du Médicament et de la Pharmacie (DMP) – Morocco - Rana Chalhoub - Regulatory Affairs Director at Mecomed. - Dr. Mona Al Moussali - Co-founder PRA Consultancy and organizer of the Afrisummit. In this part 2 we have: - Noha El-Hariri – Head Regulatory Affairs Medical Device - Mohamed Mahdy Ghonim – IVD Manufacturer in Egypt Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link ■ Noha El-Hariri LinkedIn Page: https://www.linkedin.com/in/noha-el-hariri-a46a1285/ ■ EDA Webpage: https://www.edaegypt.gov.eg/ ■ Mohamed Mahdy Ghonim LinkedIn Page: https://www.linkedin.com/in/mohamed-ghonim-1444102b/ ■ Mohamed Mahdy Ghonim Qualitech International: https://www.qt-int.nl/ ■ Thequa medical: https://www.thequa-med.com/ ■ Afrisummit: https://www.linkedin.com/company/pharmaregafrisummit/ Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 31 Oct 2023 | Validate your Iphone, Samsung Galaxy, Huawei… for your Software | 00:35:57 | |||
This MDCG came like evidence but comments on it where more confusion. What exactly was the objective of the MDCG 2023-4. We will try to explain to you on this podcast with Erik Vollebregt from Axon Lawyers. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and protection of personal data. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities, and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership of specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as for biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links ■Erik Vollebregt LinkedIn: https://www.linkedin.com/in/erikvollebregt/ ■Axon Lawyers website: https://www.axonlawyers.com/ ■MDCG 2023-4: https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf ■Blog post: medicaldevicelegal.com ■Book: https://erikvollebregt.gumroad.com/ ■Blue guide: https://single-market-economy.ec.europa.eu/news/blue-guide-implementation-product-rules-2022-published-2022-06-29_en Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 09 Nov 2023 | Medical Device News – November 2023 Regulatory Update | ||||
EU: UDI for contact lenses Master-UDI-DI: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302197 EUDAMED Roadmap It is a DRAFT: https://health.ec.europa.eu/system/files/2023-10/md_eudamed_roadmap_en.pdf MDCG 2023-4 guidance - Validate the combination with hardware https://health.ec.europa.eu/system/files/2023-10/md_mdcg_2023-4_software_en.pdf Fees and charges payable to EMA: Expert Panel will cost you money : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CONSIL:ST_14057_2023_INIT Notified Bodies : Finland and Turkey Team-NB call for action to Manufacturers to apply: https://www.team-nb.org/wp-content/uploads/2023/10/Team-NB-PressRelease-Capacity-NotifiedBodies-during-transition-IVDR-MDR-October2023.pdf
Training for you Increase your knowledge in QA RA : Vigilance Reporting in EU: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/ Green Belt training: December 11th until December 15th: https://school.easymedicaldevice.com/course/gb27 Spain: Implementation of the HTA : EU Health Technology Assessment Regulations: https://www.aemps.gob.es/la-aemps/de-la-teoria-a-la-practica-implementacion-del-reglamento-de-evaluacion-de-tecnologias-sanitarias-de-la-ue/ Regulation 2021/2282 on health technology assessment: https://health.ec.europa.eu/publications/regulation-eu-20212282-health-technology-assessment_en Switzerland: Products without an intended medical purpose : Same as EU MDR: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu600_00_007d_mb_produkte_ohne_medizinische_zweckbestimmung.pdf.download.pdf/MU600_00_007e_MB_Devices_without_an_intended_medical_purpose.pdf General procedure for foreign governmental inspections - Inform Swissmedic before governments audit a manufacturer https://www.swissmedic.ch/dam/swissmedic/en/dokumente/bewilligungen/i-308/i-308_aa_02-A01e_general_procedure_for_foreign_governmental_inspections_switzerland.pdf.download.pdf/I-308.AA.02-A01e_Merkblatt_General_procedure_foreign_govern_insp_CH_related_therapeutic_prod.pdf MedTech Conf Map of conferences available Conferences Map: https://medtechconf.com/ Medica Dusseldorf November 13 -15 : https://medtechconf.com/event/medica-2023/ TEAM-PRRC Strasbourg November 16 - 17: https://medtechconf.com/event/team-prrc-annual-summit-2023/ Turkey: Product not considered as a Medical Device - List of products available: https://titck.gov.tr/duyuru/tibbi-cihaz-yonetmelikleri-kapsaminda-degerlendirilmeyen-urunler-30102023120556 eQMS SmartEye: SmartEye is your eQMS - Ask for your DEMO : https://smart-eye.io/ USA: eStar is your new 510k : Since October 1st, 2023: https://www.fda.gov/media/152429/download Australia: Webinar on UDI for Australia - November 21st, 2023 11.30 AEDT: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-udi-webinar-19-australian-udi-project-update-and-discussing-considerations-and-real-world-benefits-adopting-udi-healthcare Podcast Nostalgia : You remember What are some pitfalls to avoid during Software Design? Weronika Michaluk: https://podcast.easymedicaldevice.com/253-2/ Affrisummit 2023 Part 1 Morad Ajan, Rana Chalhoub, Dr. Mona Al Moussali: https://podcast.easymedicaldevice.com/254-2/ Afrisummit 2023 Part 2 Nora El-Hariri and Mohamed Mahdy Ghonim: https://podcast.easymedicaldevice.com/255-2/ Validate your iPhone, Samsung Galaxy, Huawei for your Software Erik Vollebregt: https://podcast.easymedicaldevice.com/256-2/ | |||||
| 14 Nov 2023 | How to CE certify a Calculator, Risk Score…? | ||||
We have a lot of sort of Software as Medical Devices. Today I wanted to ask to Cesare Magri some questions about APIs. First what they are, and can they be a Medical Device. He will also give us some advice on what to do if your API is really a medical device. So stay tuned. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diagnostic manufacturers by leveraging clinical and non-clinical data for certification and marketing purposes. He has contributed to more than 100 clinical and performance evaluation for devices of all risk classes. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links from the Video ■ Cesare Magri LinkedIn: https://www.linkedin.com/in/cesare-magri/ ■ 4BetterDevices website: https://4betterdevices.com/ Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 21 Nov 2023 | How to find your Predicate Device for your 510K Submission? | 00:30:48 | |||
The choice of a Predicate Device is important and challenging at the same time. Your predicate device is already on the US market, so all you must do is select it and confirm that your device is the same as the predicate and Bingo, you can register your product in the US. But this is not as simple as that. Beat Keller from imt in Switzerland will share with us his experience working on US submissions and provide some hints on what you should or should not do. Who is Beat Keller? Beat is the Head of Regulatory Affairs and Quality Management at IMT, a Swiss Consultancy and Engineering Service provider for medical device manufacturers. He has worked for more than 10 years in the medical device industry first as a software engineer, then as a project leader before he took over the Regulatory and Quality department of IMT. Beat is also active in different standards working group as Co-Convenor of the “conformity assessment” working group of the Swiss standards association and member of different working groups on Swiss, European and International level for medical device standards. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ imt website: https://www.imt.ch/ US FDA predicate device guidance: https://www.fda.gov/media/171838/download MDCG Guidance on Equivalent Devices: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 28 Nov 2023 | What is the situation regarding digitalization in Medtech? | 00:43:13 | |||
Don’t miss this panel discussion that happened during the MEDXD in Berlin (26 and 27 September). Medical Device companies are moving to digitalize their processes and MDKU association did create the MEDXD conference where the discussions from multiple companies helped to understand the status. Monir El Azzouzi moderated this panel and asked questions following the presentation that were provided. This panel discussion was composed of Karim Djamshidi Vice President Global Patient Health & regulatory Compliance, Karl Storz https://www.linkedin.com/in/karim-djamshidi/
Denise Wocko Head of Global Client Portfolio Management, RQM+ https://www.linkedin.com/in/denisewocko/ Sarah Haake-Schäfer Head of Quality Management, Regulatory & Clinical Affairs, Carl Zeiss Vision Markus Pöttker PMS Lead – Safety & Surveillance, Smith + Nephew, Sarah Panten Managing Partner / Strategic Business & Product Development, avasis https://www.linkedin.com/in/sarahpanten/ Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: MEDXD link: https://medtechx.digital/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||
| 06 Dec 2023 | Medical Device News: December 2023 Regulatory Update | 00:31:42 | |||
Medboard Medboard platform Sponsor of the podcast https://www.medboard.com/ EU EPSCO Meeting November 30th. 2023 - MDR IVDR device risk of disruption: https://data.consilium.europa.eu/doc/document/ST-15385-2023-REV-2/x/pdf Survey on Medical Devices - Study supporting the monitoring of the availability of Medical Devices on the EU Market. Information: https://ec.europa.eu/eusurvey/runner/MFandAR Questionary: https://ec.europa.eu/eusurvey/files/6a4fd4cd-dfce-4fe1-bcaf-9f44eb00e471/650fed06-30d2-40b1-9ff0-e96c79b4eb96
Falsification of Medical Devices - Survey result: https://act.edqm.eu/s/XcPw5MDtYe49gmj/download/CMED-Survey-Report-Final%20%281%29.pdf MDCG 2022-11 Rev 1 Position Paper - Call to NB to streamline the certification process https://health.ec.europa.eu/system/files/2023-11/mdcg_2022-11_en.pdf EU IVDR Technical Documentation training - TEAM-NB Survey result Training IVDR technical documentation February 1st, 2024: https://www.team-nb.org/wp-content/uploads/2023/11/Leaflet-IVD-TD-Manufacturers-Training-20240201.pdf Result on Survey of MDR training: https://www.team-nb.org/mdr-technical-documentation-training-for-manufacturers/
DEHP Substance forbidden in Medical Devices - Extension to July 1st, 2030 : https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482Notified Bodies Situation - 2 new comers: Switzerland Vigilance Reporting submission information - Update your QMS procedures: https://www.swissmedic.ch/swissmedic/de/home/medizinprodukte/uebersicht-medizinprodukte/archiv/hinweis-einreichung-vigilance-meldungen-mep.html Training EU MDR Training EU MDR 2017/745 - December 11th - Green Belt Certification Program for EU MDR : https://school.easymedicaldevice.com/course/gb27 Medtech Conf Your Medtech Conferences - Register all your Events, Training, Conferences: https://medtechconf.com/ USA FDA withdrawal - not anymore member of the GHWP: https://www.fda.gov/media/174142/download Discontinuation in the USA - Notifying FDA of a permanent discontinuation: https://www.fda.gov/media/155245/download Webinar on Companion Diagnostics - Oncology Drug Products used with IVD tests: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-oncology-drug-products-used-certain-in-vitro-diagnostic-tests-pilot-program-12122023Canada Medical Device Establishment Licenses annual review - You should receive your Christmas Package: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/annual-licence-review-2024.html Saudi Arabia Webinar: Clinical Trials of Medical Device Requirements - Click on the link in December 12th, 2023: https://www.sfda.gov.sa/en/workshop/93098South Africa Guideline on Q&A for Licensing of Medical Device Establishment - Learn how to start this activity: https://www.sahpra.org.za/wp-content/uploads/2023/02/SAHPGL-MD-07_v3-Guideline-on-Questions-and-Answers-Licensing-of-Medical-Device-Establishments55.pdf Brazil Argentina & Brazil signed a Mutual Recognition Agreement - For certificates for Medical Devices: https://www.argentina.gob.ar/noticias/anmat-y-anvisa-firmaron-el-primer-acuerdo-de-reconocimiento-mutuo-en-certificados-para SmartEye eQMS for Medical Device companies - Get your Demo now: https://smart-eye.io Podcast Nostalgia How to CE certify a calculator, risk score software as Medical Device? Cesare Magri: https://podcast.easymedicaldevice.com/258-2/ How to find a predicate Device for your 510k submission? Beat Keller: https://podcast.easymedicaldevice.com/259-2/ What is the situation regarding Digitalization in the Medtech industry? MedXD https://podcast.easymedicaldevice.com/260-2/ Easy Medical Device support - info@easymedicaldevice.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice | |||||