Medical Device Regulatory Update – February 2020
In this episode, we will talk about, Coronavirus, MDCG, Notified Body, US guidance, Podcast episodes, LinkedIn Live... So don't miss it. The post Medical Device Regulatory Update – February 2020 appea...
9 Mars 20200s
Do your Economic Operators need a Quality Management System?
It is clear that a Manufacture of a Medical Device need to have a Quality Management System. But what is the answer for an importer, Distributor or Authorized Representative? You'll hear it on this ep...
4 Mars 20200s
Create your intended purpose with Cesare Magri (Medical Device)
The intended purpose of your device is critical but a lot of manufacturers are nor really putting much effort to write a good one. Check on this episode with Cesare Magri why this is important and how...
2 Mars 20200s
Medical Device School: What should verify your Economic Operators?
Your Economic Operators do have some responsibility per EU MDR and IVDR. What should they check? Monir El Azzouzi and Erik Vollebregt will help you understand that on this bonus episode. The post Medi...
26 Feb 20200s
Clinical Data for Low Risk Medical Devices with Robert van Boxtel
Many medical device manufacturers try to solve a puzzle regarding their Low risk medical devices. How to write Clinical Evaluation for it without data? here is the solution. Download the presentation....
24 Feb 20200s
Medical Device School – Who controls your Economic Operators?
In this episode we will explain you the way that Economic Operators are controlled. This may seem obvious but the answer can be different per Economic Operator. So listen to this short episode of Medi...
19 Feb 20200s
Are Brexit, Swixit, and Turkxit a reality? with Erik Vollebregt
Brexit, Swixit, Turkxit. These are the topics of this episode of the Podcast. We will try to help you understand all these -XIT and what is the impact to Medical Device manufacturers. The post Are Br...
17 Feb 20200s
Medical Device School – Who are your Economic Operators?
Who are the Economic Operators mentioned on the MDR and IVDR? This is the question that Monir El Azzouzi and Erik Vollebregt will try to answer. The post Medical Device School – Who are your Economic...
12 Feb 20200s
