Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(412)

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

Episode 28 – OBL & OEM with Stefan Bolleininger – Part 2

How an OEM or Original Equipment Manufacturer can help the OBL (Own Brand Labeller) to continue business? Stefan Bolleininger from Be-On-Quality will help us on this second part of the Podcast. The po...

16 Jun 20190s

Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]

Episode 27 – OEM & OBL Model with Stefan Bolleininger [Part 1]

The OEM and OBL model is under question with the new EU MDR and IVDR regulations. Stefan Bolleininger will help us understand how to continue to be compliant and continue business. The post Episode 27...

10 Jun 20190s

Episode 26 – IVDR preparation with Andreas Stange

Episode 26 – IVDR preparation with Andreas Stange

Andreas Stange from TÜV SÜD will help us be prepared for the new IVDR or In-Vitro Diagnostic Regulation. This is a game changer for the manufacturers as more products are on the scope of a notified Bo...

3 Jun 20190s

Episode 25 – EUDAMED secrets with Richard Houlihan

Episode 25 – EUDAMED secrets with Richard Houlihan

EUDAMED is the new European Database for Medical Devices and this is something that can change completely the world of Medical Devices. For the consumers and the manufacturers. The post Episode 25 – E...

27 Mai 20190s

Episode 24 – Myths about consultants with Thomas McMann

Episode 24 – Myths about consultants with Thomas McMann

Are you hiring contractors or consultants for your projects? Do you know the difference or do you know what are the myths about them? Thomas McMann from EPM Scientific is sharing that with us. The pos...

20 Mai 20190s

Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland

Episode 23- TOP 10 criteria to select a CRO with Alethea Wieland

Alethea Wieland, President of Clinical Research Strategies will tell us what are the most important criteria to select a good CRO for your clinical trial project. The post Episode 23- TOP 10 criteria ...

13 Mai 20190s

Episode 22 – Clinical Trial with Alethea Wieland

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 Strate...

6 Mai 20190s

Episode 21 – How to master Regulatory Affairs with Samantha Alsbury

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...

29 Apr 20190s

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