Episodes
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Prepare your transition from Class I to Class Ir
In this episode, Tautvydas will share with us its experience with Manufacturers that tries to move from Class I to Class Ir for Reusable Surgical Instruments. Don't miss it if your company is on scope. The post Prepare your transition from Class I to Class Ir appeared first on Medical Device made...
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SaMD international reach – What to consider?
The Global reach can be a problem when we talk about Medical Device. This is mainly what we will discuss with Stéphane Berger as he is trying to put globally is Software as a Medical Device in different markets. Let'S hear about the difficulty. The post SaMD international reach – What to…
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Biological Evaluation: Top Big mistakes
If you need to perform a Biological Evaluation for your Medical Device, Paul and Laura from Icare Group will be the best partners for you. Check the advice they provide. The post Biological Evaluation: Top Big mistakes appeared first on Medical Device made Easy Podcast. hamza benafqir
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Medical Device News: February 2023 Regulatory Update
Your Medical Device News is ready for the month of February 2023. This is containing some information on the extension of the EU MDR timeline so don't miss it. The post Medical Device News: February 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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How to do Post-Marketing Surveillance in the US (vs EU)?
Post marketing Surveillance for medical devices in the US market is done differently than in EU. So learn on this podcast how to be prepared with Rob Packard. We will talk about multiple sort of devices and how FDA is handling the way to do Post Marketing Surveillance so if you are selling to the...
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How to evaluate Benefit-Risk Ratio for Medical Devices?
You maybe arrived to this section of the Techniocal File asking for Risk Benefit Ratio and you don't know what to write on it. On this episode we will explain to you what are your possibilities and how you should thing about Risk-Benefit ratio with Naveen Agarwal. The post How to evaluate...
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Breaking News: EU MDR Extension Proposal is out for consultation
You asked for the extension of the transition period for MDR? Then you have the proposal for the change. Now the question is if you are satisfied and if the content is helping you? No worry if you don't like it they are expecting your immediate comment as tomorrow is the last day. The post…
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How to improve the relationship between QA – RA and Marketing?
Let's see if you can improve relationship between your industry departments and Quality and Regulatory affairs. We will talk about that with Omar M. Khateeb who will explain to us how Marketing and QA RA should work together. The post How to improve the relationship between QA – RA and Marketing?...
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Medical Device News: January 2023 Regulatory Update
All your Medical Device Regulatory update for January 2023 within 30 minutes. Listen to this podcast episode with Monir El Azzouzi The post Medical Device News: January 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Grow your LinkedIn Profile with Karandeep Badwal
If you are looking to grow your LinkedIn profile then you should listen to this episode where Karandeep Badwal will give his learning being part of the LinkedIn Creator Accelerator Program. The post Grow your LinkedIn Profile with Karandeep Badwal appeared first on Medical Device made Easy…
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Is EU MDR extended? with Erik Vollebregt
I know you all heard about the extension of transition period for the EU MDR 2017/745. This is a good news, but let'S understand what this means and how you should interpret all this as there are some misinformation that are spread and we will try to sort out all of them with Erik Vollebregt. The...
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MDCG, Team-NB, BVMed & Team-PRRC tell you all about PRRC
If you have a question about the role of a PRRC then most likely this will be answered by one of those expert. This podcast will display the Team-PRRC event where EU commission, Team-NB and BVMed answered the questions of Bassil Akra Board member of Team-PRRC The post MDCG, Team-NB, BVMed &...
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Medical Device News – December 2022 Regulatory Update
All the latest regulatory news for the Medical Device Industry in 30 minutes The post Medical Device News – December 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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How to choose the best Sterilization Method for Medical Devices?
This is a questions that I get asked when I am part of the design process of medical devices. Which Sterilization method should we choose? I invited Jane Scally to help us define the best practices when it comes to the Sterilization process. The post How to choose the best Sterilization Method…
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Why Risk Management is important to Medical Device development?
Why is Risk Management so important? This is maybe something that a lot of regulators are asking you. "Do you have your Risk Management?" In this episode, we will explain to you why this is most critical information to get. The post Why Risk Management is important to Medical Device development?...
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Regulatory Pathway: How to reach the US market? [510k exempt]
If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is 510k exempt so let's here their journey. The post...
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Your Software/IVD clinical report is completely WRONG!
If you are in the Software and IVD industry we would bet that you are making your clinical data gathering wrong. Cesare Magri will explain to you why and how to correct that. So listen carefully to his advise. The post Your Software/IVD clinical report is completely WRONG! appeared first on…
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Medical Device News – November 2022 Regulatory Update
What happened to the Medical Device industry? Let's learn in this episode with Monir El Azzouzi The post Medical Device News – November 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Can you go to Jail as a PRRC? [Elem Ayne]
You are maybe asked to become a PRRC and you start to have a lot of questions. I am sure these are the questions that you ask yourself as this is also what other people are willing to know. They contacted Elem Ayne at Team PRRC and the association is trying to help them understand the situation....
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How to be MDSAP certified for your Medical Devices?
MDSAP is now in place since few years. For those that still have no understanding of it, I will tell you all on it from who needs it to how to be prepared for it. Enjoy! The post How to be MDSAP certified for your Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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What do Clients, Followers, Team, … think of Easy Medical Device?
This is the celebration episode for the 200th consecutive week where we released the podcast. This time I asked some of the stakeholders to provide a feedback about their experience with Easy Medical Device and the Podcast. The post What do Clients, Followers, Team, … think of Easy Medical…
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How to select your Notified Body and understand the full process?
I know you are struggling with that so I will explain to you what we learned applying to multiple Notified Bodies. This is difficult and you should really plan the process ahead and not wait the last minute. The post How to select your Notified Body and understand the full process? appeared first...
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How to become the best PRRC ever? [Ronald Boumans]
PRRC is a 4 letters acronym for Person Responsible for Regulatory Compliance and you need a person to act as PRRC but also a person that can really understand how to become the best PRRC. So let's learn more about it on this podcast episode. The post How to become the best PRRC ever? [Ronald...
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Why do you need an Initial Importer for the US Market?
This is not anymore a question, you need an Importer for the US market. But what are the rules and who can do this. Stéphen Toupin from Dawa Medical will help us understand why your products are blocked at the US Customs. The post Why do you need an Initial Importer for the US Market? appeared...
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Medical Device News: September 2022 Regulatory Update
Medical Device News is your summary of what happened in the Medical Device Field. I am providing you with the September 2022 Regulatory Update. Enjoy! The post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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SaMD or SiMD – How to create your Design Dossier?
The Design Dossier of your Medical Device is really important. But what about a Software as a Medical Device. You will learn today some good practices to create them. The post SaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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New Blue Guide – What is the impact on Medical Devices?
The New Blue Guide is a guidance document that is really important to CE marking. And this has also some impact on the interpretation of the Medical Device legislation like EU MDR and IVDR. So don't miss this episode where we interpret what are the major changes. The post New Blue Guide – What is...
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Why are we not Discontinuing your Products?
Why are you not discontinuing your products? I am not talking about just deleting the reference on your portfolio but obsoleting the documents linked to this product. The post Why are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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When you think “510k” but FDA says “DeNovo” with Spencer Jones
What would you think if you planned all your regulatory strategy for FDA 510k and when you submit, the FDA says to you that this should go DeNovo. Spencer Jones will tell us what he learned during this process. The post When you think “510k” but FDA says “DeNovo” with Spencer Jones appeared first...
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How to create your Technical Documentation? [EU MDR and IVDR]
I get a lot of messages about the creation of Technical Documentation and I want to share with you how I am doing it. Don't hesitate to check the link in the show notes for more details. The post How to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made...
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Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
The use of a cleanroom is something that depends on your products. Philippe Bourbon from the laboratory Icare will explain to us what exactly is needed to install and maintain cleanrooms. The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made...
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AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
If you are working with Artifical Intelligence for your Medical Devices, then this episode is for you. We are alerting you about the new legislation that is planned for all Artificial Intelligence software. Not only medical devices, but they are included. The post AI Act vs EU MDR 2017/745 are…
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Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED)
During my visit to the Medtech Europe Forum I had the chance to meet Fabien, Peter, Ronald, Inna and Rana. They shared with me some great information. Don't miss their interview. The post Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy...
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Medical Device News – July 2022 Regulatory Update
This podcast episode is the monthly review of the regulatory situation. Don't forget to download the document with all the links. The post Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Attention! 1 year before UKCA is the law for Medical Devices in the UK
This is your last year to be compliant to UKCA otherwise Bye Bye the UK market. We tell you everything with Adam Rae on this episode. So listen carefuly and don't forget to download the cheat sheet. The post Attention! 1 year before UKCA is the law for Medical Devices in the UK appeared first on...
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Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]
We may think that ISO 13485 certification is only for Medical Device manufacturers but in this episode you will hear Cristina Miroescu from Sofmedica Group tell us why its company decided to be certified even if they are not manufacturing devices. The post Why is it great for Importers to be ISO...
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What are some Quality Common Mistakes? [Karandeep Badwal]
Karandeep Badwal will list us some of the common mistakes that he has always noticed. I will confirm some of them. If you are able to solve those you have made already 70% of the problems resolved. Enjoy! The post What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical...
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Medical Device News: June 2022 Regulatory Update
Medical device news June 2022 is focusing on IVDR 2017/746 date of applciation and consequences. Don't miss all the additional information on guidances, Training,,, The post Medical Device News: June 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea
We have worked since more than a year on an eQMS called SmartEye and I have invited Anindya Mookerjea the CEO of SCube Technologies to present the tool and talk about the advantages of electronic Quality Management Systems. The post Let’s introduce you to our eQMS SmartEye with Anindya Mookerjea...
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What to learn about the EU Medical Device situation? [Erik Vollebregt]
Medtech 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...
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What happens after the IVDR Date of Application with Colm O’Rourke
The 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…
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How to certify your Software as a Medical Device? (SaMD)
Software 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...
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Medical Device News: May 2022 Regulatory Update
In 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
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Training Process – What are the mistakes to avoid? [ISO 13485]
Great 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
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How your PMCF is evaluated by your Notified Body? [Matthias Fink]
This 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…
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How to prepare an Audit with a Front Room & a Back Room?
Have 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...
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Medical Device News: April 2022 Update
The 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
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What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
We 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...
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How to sell Medical Devices online in the EU and US?
If 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...
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What lesson did we learn doing Clinical Evaluations? [Cesare Magri]
If 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…
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