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...
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 Device made Easy Podcast . Monir El Azzouzi...
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 Device made Easy Podcast . Monir El Azzouzi...
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
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
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 made Easy Podcast . Monir El Azzouzi...
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 first on Medical Device made Easy Podcast . Monir El Azzouzi...
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
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 post What are the surprises during MDR & IVDR transition? [Erik Vollebregt] appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
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 Devices online in the EU and US? appeared first on Medical Device made Easy Podcast . Monir El Azzouzi...
