Medical Device News – April 2020 Regulatory Update
Medical Device News April 2020- We will talk about how Coronavirus is shaking the Medical Device World, the Notified Body Situation, the MDCG guidances and the Easy Medical Device events. Enjoy! The p...
4 Touko 20200s
How to calculate your sample size with Jon Bergsteinsson
Don't worry, we will not show you any equation for calculating the sample size. But we will show you how to do it and why you should be careful on some important parameters. Then you can see some exam...
27 Huhti 20200s
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
This week there was an important vote regarding the proposal to delay the EU MDR until May 26, 2021. The parliament adopted it and we wait for the publication on the official journal. But what will be...
20 Huhti 20200s
Medical Device School – Why are Staff hiding problems to QA & RA?
If you are not working in QA RA you maybe don't understand this. But sometime people don't want to follow the process not because they want to annoy you but because they are afraid of some consequence...
15 Huhti 20200s
MDR & Drug-Device Combination Products with Theresa Jeary
Did you know that the EU MDR is amending 2001/83/EC for Medicinal Products. This may have some consequences for your products if it involves a Drug-Device combination. Monir El Azzouzi and Theresa Jea...
13 Huhti 20200s
Medical Device News – March 2020 Review (EU MDR)
The month of March 2020 is over but there was a lot of information provided regarding the Medical Device industry so let's listen to the different news with Monir El Azzouzi The post Medical Device Ne...
6 Huhti 20200s
What is a Significant Change for your Medical Device? with Erik Vollebregt
This is an important question if you understand the rule for a transition period of your device under EU MDR article 120(3). If you perform a significant change then you may be prepared for the conseq...
30 Maalis 20200s
All about Class Is, Im and Ir with Elem Ayne (EU MDR 2017/745)
In this episode we will focus specifically on Medical Device class I that are "Sterile", with measuring function" or "Reusable surgical instruments". Elem Ayne will help us to understand what you shou...
23 Maalis 20200s
