Erik Vollebregt
17 Podcast Episodes
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
AI Act vs EU MDR 2017/745 are they compatible? [Erik Vollebregt]
If you are working in the development of Software, then this is maybe something that will be interesting for you. The EU... Read more
19 Jul 2022
•
What to learn about the EU Medical Device situation? [Erik Vollebregt]
What to learn about the EU Medical Device situation? [Erik Vollebregt]
The Medtech Forum occurred this year in Barcelona between May 3-5, 2022 During this conference, we recorded a podcast ep... Read more
24 May 2022
•
Similar People
Bassil Akra
Michelle Lott
Ed Drower
Justin Bushko
Natasha Bankowski
Helene Quie
Mitch Robbins
Sharon Ayd
Karandeep Badwal
Samantha Alsbury
Sean Hamilton
Angelina Hakim
Richard Young
Petra Ognjenovic
Stefan Bolleininger
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
What are the surprises during MDR & IVDR transition? [Erik Vollebregt]
There was an announcement earlier about the transfer of the Expert Panel for EU MDR & IVDR to the European Medicine ... Read more
29 Mar 2022
•
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
MDCG 2021-27 Placing on the market & Re-labelling with Erik Vollebregt
The MDCG 2021-27 on Articles 13 and 14 of the EU MDR 2017/745 is creating some problems because of the vocabulary used. ... Read more
25 Jan 2022
•
Most Popular
Elon Musk
Barack Obama
Bill Gates
LeBron James
Mark Cuban
Michelle Obama
Melinda Gates
Arnold Schwarzenegger
Kevin Hart
Terry Crews
Mike Tyson
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
Is it a good idea to sue my Notified Body? [Erik Vollebregt]
First of all, I am not encouraging anyone to sue anyone. This is only educative content to know what is possible and wha... Read more
7 Sep 2021
•
System and Procedure Pack the RETURN with Erik Vollebregt
System and Procedure Pack the RETURN with Erik Vollebregt
In this second episode on System and Procedure Pack, we answer more questions about this way to place devices on the mar... Read more
20 Jul 2021
•
MDR is coming so brace yourself with Erik Vollebregt
MDR is coming so brace yourself with Erik Vollebregt
MDR is coming In 1 week and before that, I asked Erik Vollebregt from Axon Lawyers about some questions that I receive. ... Read more
18 May 2021
•
How to certify a self-testing device under IVDR? [Erik Vollebregt]
How to certify a self-testing device under IVDR? [Erik Vollebregt]
We have talked enough about EU MDR so this week we will help the IVD Companies with the requirements for Self-testing de... Read more
26 Oct 2020
•
How can GDPR impact Medical Devices with Erik Vollebregt
How can GDPR impact Medical Devices with Erik Vollebregt
There were a lot of discussions about GDPR since its implementation in early 2018. But after a few years, some issues ar... Read more
14 Sep 2020
•
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
The 1-year delay for the EU MDR 2017/745 with Erik Vollebregt
This week I had some exciting moment when I followed the EU parlement webcast on the April 17th, plenary session to see ... Read more
20 Apr 2020
•
