Recent Posts
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Episode 22 – Clinical Trial with Alethea Wieland
What is a Clinical Trial or Clinical Investigation? And should a Medical Device Company start a Clinical Trial or perform a Clinical Evaluation? I invited Alethea Wieland from Clinical Research Strategies to help us have a better understanding. She will help beginners in this area to learn about the fundamentals of clinical trials.
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Episode 21 – How to master Regulatory Affairs with Samantha Alsbury
For those that want to work on a Regulatory Affairs department, the path can be difficult. We are looking for people that are experimented but before to be experimented they should start somewhere. So how to do that? Samantha Alsbury from TOPRA will help us on this new episode.
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Episode 20 – What is a Blockchain with Khuram Malik
Blockchain for Healthcare is a new Technology. On this episode, Khuram Malik will tell us what is Blockchain and how Medical Devices can use it.
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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 industry. Let's clarify that with Cyrille.
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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. She will also provide us some tips to find the right candidate.
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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 Engineering School
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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 he founded War On Epilepsy. Listen to his story which provides a great message.
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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 companies and also the brexit, notified bodies and finally rule 11 for the classification of Software
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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
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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 on March 29th, 2019 and for now there is no deal reached.
