Medical Device made Easy Podcast

You may be on the business of Software development and you ask yourself why your Dev team is not really happy to work with Quality and Regulatory affairs team? In this episode, we will discuss with Christophe Girardey from WEGA about the gaps and how this can be solved. The post How to connect Software dev and QA RA Team appeared first on Medical Device made Easy Podcast. hamza benafqir

Since the EU MDR extension was voted, there are still a lot of questions remaining. This is what we will try to clarify today with Florian Tolkmitt from Pro-Liance. This podcast will provide you some tips or help you avoid some great misunderstanding. The post The great misunderstanding of EU MDR amendments appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device News - june 2023 regulatory update The post Medical Device News -June 2023 regulatory update appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post How to master Regulatory Intelligence? appeared first on Medical Device made Easy Podcast. hamza benafqir

I know this is not really something that people anticipate. But the EU MDR is asking you to anticipate that. So don’t miss this as this can raise a Non-Conformance from the Notified Body during an audit if there is no plan in place. So do check what we propose to you. The post What if your Medical Device Company goes Bankrupt? appeared first on Medical Device made Easy Podcast. hamza benafqir

Technical Files inconsistency, it is when your technical file is not providing the right information or that all the information is not aligned. Here we will try to look at some of these issues. The post Technical Files Inconsistencies Identified by Notified Bodies appeared first on Medical Device made Easy Podcast. hamza benafqir

We hear so many things about UK and the timeline and now that EU issued an extension, the question is “Does this change something for UK” So on this episode we’ll review again what are the requirements to go to the UK market. The post The truth about the UK vs EU situation appeared first on Medical Device made Easy Podcast. hamza benafqir

Medical Device news - May 2023 Regulatory Update- easy medical device The post Medical Device news – May 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post Transition to Agile for Software as Medical Device appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post Prepare your audit like a PRO appeared first on Medical Device made Easy Podcast. hamza benafqir

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. The post What is a SOUP for your Software Development? appeared first on Medical Device made Easy Podcast. hamza benafqir

► Medboard platform: https://www.medboard.com/ ► Podcast page: https: //podcast.easymedicaldevice.com/226-2/ ► MEDBOARD SHOW NOTES LINKS:​​​​ https://www.medboard.com/reports/easy-medical-device-regulatory-update/2023/april/ Today on this Medical Device news for March 2023 we’ll talk about • The EU […] The post Medical Device News – March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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 […] The post How to perform Risk Management for a Software ? appeared first on Medical Device made Easy Podcast. hamza benafqir

The postmarketing surveillance is a major process within the EU MDR. Today Marcus Emne from Hoodin will explain to us how this is working and how the Artificial intelligence may help. The post How to create a Proactive Postmarketing Surveillance? [EU MDR] appeared first on Medical Device made Easy Podcast. hamza benafqir

Vigilance Reporting is one of the process that everyone should have but that no one wants to use. So this is really difficult to understand all the requirements to it. Also knowing that this may change from one coutry to another. The post What you should know about Vigilance Reporting for Medical Devices? appeared first on Medical Device made Easy Podcast. hamza benafqir

A lot of information within this update. So check the show notes as this may be a bit too much for you. This March Update is going through Europe but also US, Middle East, South Africa. A world tour. lol The post Medical Device News: March 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

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 Easy Podcast. hamza benafqir

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 consider? appeared first on Medical Device made Easy Podcast. hamza benafqir

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

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

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 US market, check this. The post How to do Post-Marketing Surveillance in the US (vs EU)? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Benefit-Risk Ratio for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Breaking News: EU MDR Extension Proposal is out for consultation appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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 Podcast. Monir El Azzouzi

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 post Is EU MDR extended? with Erik Vollebregt appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 & Team-PRRC tell you all about PRRC appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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 for Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Medical Device made Easy Podcast. Monir El Azzouzi

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

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. The post Can you go to Jail as a PRRC? [Elem Ayne] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

This monthly episode will provide you with all the latest updates for the Medical Device industry in EU, UK, Switzerland, and the rest of the world. So don't miss it. The post Medical Device News – October 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Device? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 on Medical Device made Easy Podcast. Monir El Azzouzi

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 Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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

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 the impact on Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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

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 on Medical Device made Easy Podcast. Monir El Azzouzi

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 Easy Podcast. Monir El Azzouzi

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 Easy Podcast. Monir El Azzouzi

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 they compatible? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

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 Podcast. Monir El Azzouzi