![What to learn about the EU Medical Device situation? [Erik Vollebregt]](https://cdn.podme.com/assets/podcast_img_placeholder_small.jpg)
What to learn about the EU Medical Device situation? [Erik Vollebregt]
Medtech Forum was really a great event with all the Medical Device stakeholders at the same place. Manufacturers, Consultants, Notified Body, European Commission, trade associations, service providers...
24 Maj 20220s
What happens after the IVDR Date of Application with Colm O’Rourke
The IVDR 2017/746 will go live and this may be a big problem for a lot of companies. We will talk about that with Colm O'Rourke from Trinzo. The IVDR is changing the game so learn about it. The post W...
17 Maj 20220s
How to certify your Software as a Medical Device? (SaMD)
Software as a Medical Device is an area that is exploding. So understanding how this is working and what to be done is important. Listen to this episode to have more clarity on your projects for EU an...
10 Maj 20220s
Medical Device News: May 2022 Regulatory Update
In this episode, we will review all the changes related to Quality & Regulatory Affairs for Medical Devices in the month of May 2022. The post Medical Device News: May 2022 Regulatory Update appeared ...
3 Maj 20220s
Training Process – What are the mistakes to avoid? [ISO 13485]
Great episode with Rod and Katie on Training Requirements. A lot of afvices that can help you pass audits and remain compliant The post Training Process – What are the mistakes to avoid? [ISO 13485] a...
26 Apr 20220s
How your PMCF is evaluated by your Notified Body? [Matthias Fink]
This podcast episode will be instrumental for you as PMCF should be part of your strategy. And Matthias Fink from TÜV SÜD will provide you with great advice on how to overcome this task. The post How ...
19 Apr 20220s
How to prepare an Audit with a Front Room & a Back Room?
Have you ever performed an audit with a Front Room and Back Room? In this episode I will explain to you how this works and what is the interest. This method can help you to have a smooth audit and mak...
12 Apr 20220s
Medical Device News: April 2022 Update
The latest news for the Medical Device Community is on the Medical Device News Podcast. We'll talk about EU, US, MEA, Asia, Notified Bodies, Events, Podcasts. So enjoy! The post Medical Device News: A...
5 Apr 20220s
