Medical Device made Easy Podcast

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 block...

13 Sep 20220s

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 Regu...

6 Sep 20220s

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 cr...

30 Aug 20220s

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 m...

23 Aug 20220s

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 Discontin...

16 Aug 20220s

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 thi...

9 Aug 20220s

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 ...

2 Aug 20220s

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 May...

26 Jul 20220s