Episode 19 – Rule 11 for Software Devices with Cyrille Michaud
Cyrille Michaud from MD101 Consulting is helping us to understand the new rule 11 to classify Software Devices in the European Union. This is a new rule so this creates a lot of discussion in the indu...
15 Apr 20190s
Episode 18 – QA RA Recruitment situation with Petra Ognjenovic
Is it the right moment to move to another position if you are in Quality and Regulatory affairs? Petra Ognjenovic from SciPro Global is helping us to decode the situation on the recruitment market. Sh...
8 Apr 20190s
Episode 17 – Unannounced audit stories with Florent Guyon
On this new Episode, Florent Guyon from Nexialist is sharing with us his anecdotes regarding unannounced audit. He will also talk to us about a Master Degree he proposes at the ISIFC Biomedical Engine...
1 Apr 20190s
Episode 16 – From Disease to a Medical Device with Sean Hamilton
Sean Hamilton from War on Epilepsy is a Seanpreneur as he says on this episode. He is epileptic and this made him think that he can maybe create a Medical Device for people with the same condition. So...
25 Mar 20190s
Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2
On this second part of the podcast episode, Erik Vollebregt is continuing to tell us more stories on the background of the MDR and IVDR. We'll discuss about the differences between big and small compa...
18 Mar 20190s
Episode 14 – MDR & IVDR stories with Erik Vollebregt (Part 1)
Erik Vollebregt from Axon Lawyer is explaining to us what is the EU MDR and IVDR. This will be a 2 part episode with a lot of anecdotes. Erik is also the author of the blog MedicalDevicesLegal.com The...
11 Mar 20190s
Episode 13 – Brexit Talk with Richard Young
Richard Young from Sensus group talk to us about the Brexit Situation. His company is located in the UK and is helping Medical Device manufacturers to overcome this situation. Brexit date is planned o...
4 Mar 20190s
Episode 12 – How to create an ISO Standard with Marcelo Antunes
Marcelo Antunes from SQR Consulting is walking us through the process of Standard creation. You'll understand how you can participate to it and why it is so important. We will also discuss about the ...
25 Feb 20190s
