Medical Device News – October 2021 Regulatory Update
Here is the Regulatory update for October 2021. We will talk of the Implementation of MDR and IVDR, MHRA, Swissmedic, FDA, AEMPS.. A new session of the Green Belt opens this month. The post Medical De...
5 Okt 20210s
Why does an Importer/Distributor need to appoint a Notified Body?
The MDR and IVDR has not finished to surprise us. On this episode we will talk about the article 16(4) where we see that in certain circumstances, an importer or Distributor will need to get certified...
28 Sep 20210s
How to collect Clinical Data within the 21st Century [Jon Bergsteinsson]
Are you starting a clinical investigation or PMCF? Then are you using a Digital Solution to collect the data? Today we will explain to you what is The post How to collect Clinical Data within the 21st...
21 Sep 20210s
How to manage the IVDR transition period? [IVDR 2017/745]
We have passed the Date of application for MDR and this went well because a lot of manufacturers do have CE certificates that expire later. But for IVDR this is another story. So for the majority of t...
14 Sep 20210s
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
Maybe some of dreamed of it, maybe this idea went through your mind but you haven't done it. Here we will talk with Erik Vollebregt of the consequences of opening a legal case with your Notified Body....
7 Sep 20210s
Medical Device News – September 2021 Latest Updates
On this September 2021 update we will talk about FDA, MHRA, Swissmedic, ANSM, Fimea, MDCG guidances, New Notified Bodies... A lot to talk about so don't miss this update. If you are not willing to rea...
31 Aug 20210s
How to Certify a Software as Medical Device? (Dr. Abtin Rad – TÜV SÜD)
There are a lot of questions about Software as Medical Devices. So I have invited Dr. Abtin Rad from TÜV SÜD to give us more information about how to consider SaMD with the EU MDR 2017/745 The post Ho...
24 Aug 20210s
Better to be a Consultant or a Full-time employee? [Lifescience industry]
This is a question I asked myself when I started my career. I am now an independant consultant but I started as a Full-time employee. So Smahan will help us understand which option can be the best for...
17 Aug 20210s
