Medical Device made Easy Podcast

EU MDR is a new regulation and if you have not started a project like that you need to understand that it is costing. Not only money but time, resource... So listen to this episode if you want to unde...

19 Okt 20200s

Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia...

12 Okt 20200s

This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest new...

5 Okt 20200s

ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific...

28 Sep 20200s

In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that...

21 Sep 20200s

GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this techn...

14 Sep 20200s

The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then ...

7 Sep 20200s

In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today. The post Medi...

31 Aug 20200s