Medical Device made Easy Podcast

The usability is a term that seems complicated but within this episode Michael Engler we will try to explain to you in simple terms how you can succeed within your project. So don’t miss this episode ...

12 Joulu 20230s

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 Joulu 20230s

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 Marras 20230s

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 Marras 20230s

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 Marras 20230s

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 Marras 20230s

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 Loka 20230s

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 Loka 20230s