Medical Device made Easy Podcast

Process Validation is an important but difficult topic. You should not only be good at engineering but also at explaining to your staff. Because a good validation worth nothing if the Staff is not fol...

22 Jun 20200s

In this episode, I will help you understand the power of Internal Audits. Some of you are using that just because ISO is requiring it but you can get so much out of it. The post How to execute your In...

15 Jun 20200s

The Month of May 2020 was supposed to be the beginning of the EU MDR. This was not as the new date is on May 26th, 2021. We will celebrate the Non-Anniversary of it and also talk about IVDR, MDCG, Not...

8 Jun 20200s

Sufficient Clinical Data is a new vocabulary introduced with the EU MDR 2017/745 but this is still unclear what is sufficient and what is too weak. Bassil Akra from QUNIQUE Group will explain to you w...

1 Jun 20200s

If you are looking for a Notified Body for your Medical Device, you maybe have some difficulties to find one. In this episode, Bassil Akra from TÜV SÜD will explain to you the reason of this. The post...

25 Mai 20200s

I'll answer one of the most frequently asked question I receive from my followers. How to get ISO 13485 certified? Don't miss the links on the show notes to get more material to read. The post How to ...

18 Mai 20200s

You are maybe a Digital Health Application developer, so this podcast will be of a great interest for you. If you don't place to make your device available in germany, than DIGA may help you change yo...

11 Mai 20200s

Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! The p...

4 Mai 20200s