What is the QA RA Mindset with Michelle Lott
If you are thinking that you are the only one that has issues as QA RA, then listen to this episode. I hope this will help you to understand that there is a certain mindset to have when you do this ty...
9 Feb 20210s
February 2021 Update – Medical Devices Remote Audit by the EU
On this podcast episode, we'll perform the February 2021 update. What happened in the Medical Device World. One of the HOT TOPICS is the Remote audit authorization by the EU Commission but we'll see t...
2 Feb 20210s
How to perform your PMS more easily with Ivan Perez Chamorro?
PMS is an action that take some hours to perform. But with all the information generated, it get worse and worse. So I have invited Ivan Perez Chamorro, the Founder and CEO of Medboard to help us unde...
26 Jan 20210s
How to get the MDR certification for Artificial Intelligence Softwares?
The new EU MDR is now taking into account dangerous Software as a Medical Device SAMD. In this episode we will talk specifically about Artificial Intelligence Software. How to make them safe and effic...
19 Jan 20210s
How to register a Medical Device in Israel? (Liat Nadel)
Liat Nadel is the CEO of L.S. Marketing & Registration. She will help us to understand the context for the registration of Medical Devices in Israel. The post How to register a Medical Device in Israe...
12 Jan 20210s
Medical Device News – January 2021 Update (Monir El Azzouzi)
In this first episode of 2021 we provide you an update of the Medical Device Regulation situation. We will talk about Brexit, Swixit, Turkxit, MDCG, Notified Bodies, Approved Bodies, Trainings, Podcas...
5 Jan 20210s
How Easy Medical Device can help you? (Monir El Azzouzi)
This is the last episode of 2020 and I wanted to share with you the progress of the Easy Medical Device project. I will also tell you the next steps that I will try to achieve. Let me know how I can h...
28 Des 20200s
How to deal with Significant Changes within MDR & IVDR with Martin Witte
Martin Witte from TÜV SÜD will help us to understand the significant changes to your devices and the consequence of it for your CE Certificate. You will have to listen carefully if you are selling med...
21 Des 20200s
