Medical Device made Easy Podcast Archiv
417 Episoden
![How to become the best PRRC ever? [Ronald Boumans]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083660/how-to-become-the-best-prrc-ever-ronald-boumans.png)
1 Minute
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
The post How to become the best PRRC ever? [Ronald Boumans] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Why do you need an Initial Importer for the US Market? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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 post Medical Device News: September 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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 post SaMD or SiMD – How to create your Design Dossier? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post New Blue Guide – What is the impact on Medical Devices? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Why are we not Discontinuing your Products? appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post When you think “510k” but FDA says “DeNovo” with Spencer Jones appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![How to create your Technical Documentation? [EU MDR and IVDR]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083680/how-to-create-your-technical-documentation-eu-mdr-and-ivdr.png)
1 Minute
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 post How to create your Technical Documentation? [EU MDR and IVDR] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Maybe you need a Cleanroom? Let’s check with Philippe Bourbon appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
![AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083686/ai-act-vs-eu-mdr-2017745-are-they-compatible-erik-vollebregt.png)
1 Minute
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
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
1 Minute
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
The post Medtech Europe Forum interviews (MDR, EUDAMED, CER & MECOMED) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
The post Medical Device News – July 2022 Regulatory Update appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
1 Minute
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
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
![Why is it great for Importers to be ISO 13485 certified? [Cristina Miroescu]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083697/why-is-it-great-for-importers-to-be-iso-13485-certified-cristina-miroescu.png)
1 Minute
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
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
![What are some Quality Common Mistakes? [Karandeep Badwal]](https://cdn.podcastcms.de/images/shows/175/983314/s/665083701/what-are-some-quality-common-mistakes-karandeep-badwal.png)
1 Minute
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
The post What are some Quality Common Mistakes? [Karandeep Badwal] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
