Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(404)

How to register your Medical Device in the ASEAN region?

How to register your Medical Device in the ASEAN region?

Michael Wetherington will by your instructor in this episode. He will provide you all the information to register your product in the ASEAN region. This is the countries located in the South East Asia...

12 Okt 20200s

The latest news on Brexit, Swixit and EU MDR [Medical Device News]

The latest news on Brexit, Swixit and EU MDR [Medical Device News]

This month a lot of exists on the Medical Device news. We are still under a pandemic so conferences are going virtual and Easy Medical Devices has the best training for EU MDR. The post The latest new...

5 Okt 20200s

How to register ATMP-Device combination products?

How to register ATMP-Device combination products?

ATMP is a category of product not so well known by the regulatory affairs professionals. I wanted to help you understand how they are working with Margareth Jorvid. She will provide us with a specific...

28 Sep 20200s

How to get some help from Medical Device Regulators with Cliff Bleustein

How to get some help from Medical Device Regulators with Cliff Bleustein

In this case study we will see how Apos Therapy was able to register his product in the US for certain therapy. Cliff Bleustein; President and CEO of Apos Therapy is my guest today and you'll see that...

21 Sep 20200s

How can GDPR impact Medical Devices with Erik Vollebregt

How can GDPR impact Medical Devices with Erik Vollebregt

GDPR is not specific to medical devices, but any judgment that is issued can impact devices. And this is the case with the SHREMS II case. Erik Vollebregt accepted to answer my questions on this techn...

14 Sep 20200s

Be successful at your MDR and IVDR audit with Martin Witte

Be successful at your MDR and IVDR audit with Martin Witte

The audit for a Medical Device company can be a real struggle if this was not correctly prepared. If you want to understand what a Notified Body is looking for when it is coming to your company, then ...

7 Sep 20200s

Medical Device News – August 2020 Review (Monir El Azzouzi)

Medical Device News – August 2020 Review (Monir El Azzouzi)

In this episode we will talk about the UDI FAQ, the new regulation for reprocessing of single use devices, the EUDAMED actor module, the new Guidances released... A lot to discuss today. The post Medi...

31 Aug 20200s

How to switch quickly to a Virtual Conference with TOPRA

How to switch quickly to a Virtual Conference with TOPRA

Kevin Pay and Raluca Radu from TOPRA are helping us to understand how a virtual conference can bring the same type of experience as a normal one. This year the TOPRA Symposium will be virtual so you c...

24 Aug 20200s

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