Why do you need an Initial Importer for the US Market?
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 Syys 20220s
Medical Device News: September 2022 Regulatory Update
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 Syys 20220s
SaMD or SiMD – How to create your Design Dossier?
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 Elo 20220s
New Blue Guide – What is the impact on Medical Devices?
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 Elo 20220s
Why are we not Discontinuing your Products?
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 Elo 20220s
When you think “510k” but FDA says “DeNovo” with Spencer Jones
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 Elo 20220s
How to create your Technical Documentation? [EU MDR and IVDR]
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 Elo 20220s
Maybe you need a Cleanroom? Let’s check with Philippe Bourbon
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 Heinä 20220s
