
Medical Device News: December 2023 Regulatory Update
This is the last Medical Device News of 2023 so I hope this will contain all information needed. Enjoy your Regulatory Update! The post Medical Device News: December 2023 Regulatory Update appeared fi...
5 Des 20230s

What is the situation regarding digitalization in Medtech?
During the MEDXD in Berlin, we had a panel discussion on digitalization. Monir El Azzouzi was moderating it with some expert in Medical Device digitalization topics. The post What is the situation reg...
28 Nov 20230s

How to find your Predicate Device for your 510K Submission?
In this episode, Beat Keller from imt will be helping us to understand the secrets of Predicate Devices. This is specific to the US Market, but we will also make few parallels with the EU as we have a...
21 Nov 20230s

How to CE certify a Calculator, Risk Score…?
In this episode, Cesare Magri will help us understand how API can be considered as a Medical Device. Some calculators are existing and also used as API. So should those API developers create a QMS and...
14 Nov 20230s

Medical Device News – November 2023 Regulatory Update
This episode will be your Update of what happened within the Medical Device community. Check the show notes for all the links. Use these updates also for your QMS Regulatory updates so don’t hesitate ...
9 Nov 20230s

Validate your Iphone, Samsung Galaxy, Huawei… for your Software
MDCG 2023-4 was released and this raised a lot of questions or concerns. If you are using a software and for the functioning of it you need sensors or cameras from a third party device like a smartpho...
31 Okt 20230s

Afrisummit 2023 Interviews Part 2 – Egypt Situation
This is part 2 of the interviews made at Afrisummit. I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Mid...
24 Okt 20230s

Afrisummit 2023 Interviews Part 1
When I was at the Afrisummit I was able to interview some key stakeholders. I am sharing with you these interviews and I hope this will help you understand the situation in Middle East and Africa. Th...
17 Okt 20230s



















