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...
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
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 Medical Device made Easy Podcast . Monir El Azzouzi...
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 13485 certified? [Cristina Miroescu] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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 Device made Easy Podcast . Monir El Azzouzi...
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
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 appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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 situation? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
