Medical Device made Easy Podcast
295 episodes - English - Latest episode: 20 days ago - ★★★★★ - 17 ratingsListen Medical Device Regulation and Standards
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Episodes
What to learn about the EU Medical Device situation? [Erik Vollebregt]
May 24, 2022 00:45Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers. Let's summarize that with Erik Vollebregt. The post What to learn about the EU Medical Device situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What happens after the IVDR Date of Application with Colm O’Rourke
May 17, 2022 00:00The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it. The post What happens after the IVDR Date of Application with Colm O’Rourke appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to certify your Software as a Medical Device? (SaMD)
May 10, 2022 00:00Software as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU and US. The post How to certify your Software as a Medical Device? (SaMD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News: May 2022 Regulatory Update
May 03, 2022 00:50In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022. The post Medical Device News: May 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Training Process – What are the mistakes to avoid? [ISO 13485]
April 26, 2022 00:30Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant The post Training Process – What are the mistakes to avoid? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
April 19, 2022 02:00This podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task. The post How your PMCF is evaluated by your Notified Body? [Matthias Fink] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to prepare an Audit with a Front Room & a Back Room?
April 12, 2022 01:00Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and make your auditor happy. The post How to prepare an Audit with a Front Room & a Back Room? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News: April 2022 Update
April 05, 2022 02:00The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy! The post Medical Device News: April 2022 Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
March 29, 2022 00:00We update you on the situation regarding the MDR and IVDR transition period. Erik Vollebregt will try to provide an explanation why the EMA will now take the control of the Expert Panel for Medical Devices and also why the proposal for a 2 years or more additional transition will be needed. The post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to sell Medical Devices online in the EU and US?
March 22, 2022 00:00If you are selling medical devices online or if you plan to sell some, then this episode is for you. This will help you to understand the struggle that you may have or will encounter. Michael Wetherington and I will provide you the keys to be successful in that field. The post How to sell Medical Devices online in the EU and US? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
March 15, 2022 00:43If you are not sure of your Clinical Evaluation, then maybe by listening that you will have a better understanding of what is expected from you. So don't miss the lesson learned with Cesare Magri The post What lesson did we learn doing Clinical Evaluations? [Cesare Magri] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why do we need the Common Specification for Class D IVDR?
March 08, 2022 00:00You will hear more and more about IVDR and now we talk of the Draft Common Specification. Have a look at the explanation from Andreas that will help you be more efficient if your products are on scope. The post Why do we need the Common Specification for Class D IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – March 2022 Regulatory Update
March 01, 2022 01:00This month the big news is about FDA amending QSR to integrate ISO 13485. Not sure on how this will be at the end but it's always cool to have harmonization. No worries, other topics like IVDR, MDCG, UK, Saudi Arabia, Spain are mentioned. Enjoy!!! The post Medical Device News – March 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why would you need a Swiss Authorised Representative and Importer?
February 22, 2022 01:00What is the role of a Swiss Authorized Representative and Swiss Importer? And most importantly why would you need one? I'll tell you everything on this podcast episode. The post Why would you need a Swiss Authorised Representative and Importer? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to be great at Management Reviews? [ISO 13485]
February 15, 2022 00:30Management Review is one of the most important activity to perform before to be ISO 13485 certified. So today I will explain to you how to be great at it. The post How to be great at Management Reviews? [ISO 13485] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why Design History File (DHF) is so important? [Alexandros Savvidis]
February 08, 2022 00:00DHF is an accronym that people don't really understand and in this episode Alexandros Savvidis he tries to help us have a view of his experience. The post Why Design History File (DHF) is so important? [Alexandros Savvidis] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News: February 2022 Regulatory Update
February 01, 2022 00:00All the February 2022 updates on MDR and IVDR, Clinical requirements and some news on the guidances and Notified Bodies. The post Medical Device News: February 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
January 25, 2022 00:00The use of certain wording can be a big problem and this is what we will describe here with this MDCG guidance that is not really clarifying the situation but creating more problems. Let us tell you. The post MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to interview your QA RA Candidates? [Mitch Robbins]
January 18, 2022 00:00What is your method to perform an interview? You are not trained as a recruiter so how should you do to interview a QA RA Candidate. This is what Mitch Robbins will explain to you on this episode. So no more misses. The post How to interview your QA RA Candidates? [Mitch Robbins] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to accelerate your Laboratory Test Results? [Christoph Lindner]
January 11, 2022 02:00Lab Tests can be really tricky for the success of your Medical Device Design. We will help you in this episode to understand with Christoph Lindner. Check show notes for more details. The post How to accelerate your Laboratory Test Results? [Christoph Lindner] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – January 2022 [Happy New Year]
January 04, 2022 03:00HAPPY NEW YEAR 2022! Another year passed and this went really fast. But the Medical Device News is still here. So today we will talk of all the releases done in December 2021 and what is planned for the following months. Don't miss it. This will save you a lot of time. The post Medical Device News – January 2022 [Happy New Year] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What happened in 2021? Summary for the Medical Device Industry
December 28, 2021 02:00I know, already the end of 2021. So many things happened that this may be difficult to summarize. So I've tried to put my TOP information on this episode. I also share with you the new projects for Easy Medical Device so don't hesitate to contact us if you need our support. The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
The Step-by-Step recipe to get MDR & IVDR Certified
December 21, 2021 02:00For this episode, I wanted to show you how it is possible to plan your MDR & IVDR certification. This is a question that people ask me when they reach out. “What should I do to get ready for MDR or IVDR certification?” So here we will talk about: Quality Management System Technical Documentation Clinical Evaluation Audit readiness Audit completion Certification I hope this will help you in your process. In case you need support don’t hesitate to reach out. My team and I are...
The Step-by-Step recipe to get MDR & IVDR Certified
December 21, 2021 02:00For this christmas season, I wanted to summaries the situation on how to get MDR & IVDR certified. So i made this step-by-step recipe where you just need to follow. I hope you'll enjoy. The post The Step-by-Step recipe to get MDR & IVDR Certified appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Which devices cannot be Custom-made? [Erik Vollebregt]
December 14, 2021 00:00If you are not aware, the EU MDR 2017/745 is completely changing the definition of Custom-made devices and this is mainly what we will try to explain to you on this episode. If you still have some question,s don't hesitate to contact me. The post Which devices cannot be Custom-made? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News: December 2021 Regulatory Update
December 07, 2021 02:00Here is the last Medical Device News for this year, I will cover all the updates that happen in the EU, UK, Switzerland,, US and Saudi Arabia. We will also review the situation for Notified Bodies. I hope you'll enjoy. The post Medical Device News: December 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Let’s unleash “MDR Classification surprises” [MDR 2017/745]
November 30, 2021 02:00The MDR classification was hidding some surprises and I have asked Frank Matzek from Biotronik to tell us more about the products and rules we need to take care of. So Enjoy! The post Let’s unleash “MDR Classification surprises” [MDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Let’s unleash "MDR Classification surprises” [MDR 2017/745]
November 30, 2021 02:00Recently the MDCG guidance for Medical Device classification was published. And I wanted to have someone to help us decode it. Frank Matzek accepted to share his knowledge as he worked on the consultation of this guidance and he can tell us if there are some specific elements to look at. The discussion of today will be mainly on the changes related to the new EU MDR 2017/745. We will also discuss a bit of the EU MDD 93/42/EC Who is Frank Matzek? Frank Matzek is a Medical Device expert w...
How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD]
November 23, 2021 02:00Really great discussion with Dr Royth von Hahn from TÜV SÜD. He is providing some solutions on how to talk to your Notified Body. This would help Medical Device manufacturers. The post How to approach your Notified Bodies? [Dr. Royth von Hahn – TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Is it possible to Private Label a Medical Device under MDR & IVDR?
November 16, 2021 02:18If you are a company buying products from a supplier and then putting your brand on it to sell it in Europe, then you are an Own Brand Labeller or Private Labeller, or Virtual Manufacturer. In this episode, we will discuss this business model and what are the options for you as this is not really possible under EU MDR 2017/745 or EU IVDR 2017/746. Erik Vollebregt will provide some information on some cases where OBL is involved and also explain your choices, like importer or distributor…...
Is it possible to Private Label a Medical Device under MDR & IVDR?
November 16, 2021 02:18OEM OBL is really used a lot by Medical Device Manufacturers. But this is not possible anymore with EU MDR. So please listen to that as maybe you are doing it without knowing. The post Is it possible to Private Label a Medical Device under MDR & IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to improve your QA RA Communication with Lesley Worthington?
November 09, 2021 02:00Lesley Worthington is a career coach and will help you understand why improving your communication skills within QA RA can be a booster for you. We will talk about our experience as she also worked in QA RA. So don't miss this episode if you don't understand why your communication activities are not helping you. The post How to improve your QA RA Communication with Lesley Worthington? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – November 2021 latest update
November 02, 2021 03:00Latest update will focus on IVDR proposal, Artificial intelligence, Notified Bodies situation and MDCG guidances. Other elements will also be discussed. I hope you'll enjoy! The post Medical Device News – November 2021 latest update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How does the EU Commission plan to save IVDR 2017/746?
October 26, 2021 01:20BREAKING NEWS: The EU Commission issued a proposal to delay some IVDR date of application but it is not a complete postponment so don't use this word. Listen the interpretation of Erik Vollebregt on that. The post How does the EU Commission plan to save IVDR 2017/746? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to comply with MDR when products contain CMR Substances?
October 19, 2021 02:00Ana Luiza is my guest and we will explain to you how to be sure that your are compliant with CMR substances on your product. CMR will be reviewed during an audit and apparently there were a lot of mistakes. So let's help you to avoid that. The post How to comply with MDR when products contain CMR Substances? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
EUDAMED Update: Should you register your medical devices now?
October 12, 2021 02:00EUDAMED is the database that will provide all the information about your company and your devices. After the release of the Economic Operator module, now there is the release of the Device Registration and Certificate Module. So let's talk about that with Richard Houlihan from Eudamed.com The post EUDAMED Update: Should you register your medical devices now? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – October 2021 Regulatory Update
October 05, 2021 02:30Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post Medical Device News – October 2021 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Why does an Importer/Distributor need to appoint a Notified Body?
September 28, 2021 00:00The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified by a Notified Body even if they are not doing a manufacturing activity. So don't miss that. The post Why does an Importer/Distributor need to appoint a Notified Body? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
September 21, 2021 01:00Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post How to collect Clinical Data within the 21st Century [Jon Bergsteinsson] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to manage the IVDR transition period? [IVDR 2017/745]
September 14, 2021 00:00We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of the products, they should be compliant by the date of application. Let me explain that to you on this episode. The post How to manage the IVDR transition period? [IVDR 2017/745] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
September 07, 2021 00:00Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body. The post Is it a good idea to sue my Notified Body? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – September 2021 Latest Updates
August 31, 2021 00:00On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to read the guidances, let me summarize it for you. The post Medical Device News – September 2021 Latest Updates appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
August 24, 2021 00:00There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745 The post How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Better to be a Consultant or a Full-time employee? [Lifescience industry]
August 17, 2021 00:00This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for you. The post Better to be a Consultant or a Full-time employee? [Lifescience industry] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD]
August 10, 2021 00:00We talked a lot about MDR and tried to teach most of its requirements. And today we will continue by providing you with the Most Common Mistakes that are discovered by Notified Bodies. Martin Witte from TÜV SÜD will share with us the issues that are discovered by its team. Let's learn from it. The post What can we learn from the first MDR audits? [Martin Witte -TÜV SÜD] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News – August 2021 Regulatory Update [MDR & IVDR]
August 03, 2021 00:00This is already Mi-Year with the summer holiday. But EU Commission didn't sleep as there was a lot of MDCG guidance released. Let's review the agenda for this month and don't miss all the links. The post Medical Device News – August 2021 Regulatory Update [MDR & IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to implement Vigilance Reporting for MDR and IVDR?
July 27, 2021 00:00Vigilance Reporting is an important system to have within your quality management system. Even if you are still MDD, you need to comply to the MDR requirements for it. So I will help you for that. The post How to implement Vigilance Reporting for MDR and IVDR? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
System and Procedure Pack the RETURN with Erik Vollebregt
July 20, 2021 00:00After receiving a lot of questions on System and Procedure pack we have decided to have a second episode on it with Erik Vollebregt. So let's review some special cases and also some feedback from the authorities. The post System and Procedure Pack the RETURN with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
How to interpret the first Expert Panel Opinion? [Bassil Akra]
July 13, 2021 00:00Bassil Akra will help use interpret this first Expert Panel Opinion. Bassil already helped on a previous episode where we discussed about the creation of this Expert Panel. Let's review this first outcome and see the consequence of it for the industry. The post How to interpret the first Expert Panel Opinion? [Bassil Akra] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA]
July 06, 2021 00:00We will update you on all what happened within the Medical Device regulation. All new The post Medical Device News: The July 2021 Update [MDR IVDR FDA SFDA] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi