Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
PMCF is a key element of the Post-Marketing Surveillance process. As there were a lot of questions about it then I decided to ask Helene Quie some questions while I was at Medica 2019. The post Post-M...
6 Tammi 20200s
I wish you a Happy New Year 2020 with Monir El Azzouzi
This is the last episode of 2019 and I wanted to summaries the situation and introduce you to my 2020 projects. The post I wish you a Happy New Year 2020 with Monir El Azzouzi appeared first on Medica...
30 Joulu 20190s
6 ways to collect Clinical Data with David Rutledge
With the MDR, more and more clinical data are needed. But how will you collect them. David Rutledge will show you 6 ways to collect those data and the pros and cons for each of them. The post 6 ways t...
23 Joulu 20190s
Class I Medical Devices under MDR with Erik Vollebregt (PART 2)
Before to look at this episode, you should go to Part 1. On this second part we'll continue to discuss Class I up-classified situation and then pure Class I devices under MDR. The post Class I Medica...
16 Joulu 20190s
Corrigendum 2 – Changes for Class I Devices with Erik Vollebregt (Part 1)
The MDR Corrigendum 2 is changing the rules for some class I devices under MDD that are up classified under MDR. Let's see what manufacturers should do. The post Corrigendum 2 – Changes for Class I De...
9 Joulu 20190s
How to evaluate your Medical Devices in 3 Steps with Heikki Pitkänen?
If you have a product and you want to evaluate if this is a Medical Device, then you need to follow the 3 steps that we will discuss on this episode. Heikki Pitkänen's platform is providing a solution...
2 Joulu 20190s
Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch
What is the role of a Distributor within the new MDR 2017/745 and IVDR 2017/746. This is the question that I asked my guest who is working as distributor of Medical Devices in Norway. The post Respons...
25 Marras 20190s
Medical Device School: Product Development or Documentation creation?
When you are trying to create your product there is one question that you should answer: Should you focus on your product development or your documentation creation? Listen to our argument on this epi...
21 Marras 20190s
