To be able to sell products in different countries, you need to understand what are the requirements for each of them. This is where the Regulatory Affairs department is helping. In this episode we wi

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

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

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

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

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 dont hesitate

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

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

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. The

When we develop a Software, there are some pitfalls that you can avoid. Weronika Michaluk from HTD Health will explain to us how to do that. Dont miss this to accelerate your development and avoid to