Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Avsnitt(405)

How to register a Medical Device in Mexico? [Josué Garza]

How to register a Medical Device in Mexico? [Josué Garza]

You maybe know how to register your devices in Europe or USA now. But let's discover how we can do that in Mexico with Josué Garza from IPS or Insumos para la salud. You'll learn the 3 pathways to do ...

14 Dec 20200s

Medical Device News: What happened in November 2020?

Medical Device News: What happened in November 2020?

This November update is providing a lot of information on what you should not miss. We will talk Brexit, Eudamed, Jobs, Training... A lot of topic to help you stay up-to-date. The post Medical Device ...

7 Dec 20200s

Is it Easy for a Notified Body to get EU MDR accredited?

Is it Easy for a Notified Body to get EU MDR accredited?

In this episode, we will hear the journey of a Notified Body to get EU MDR accredited. We hope this will help you to understand how difficult it is and why you should be patient with your Notified Bod...

30 Nov 20200s

How a Quality & Regulatory training can help you? [Sofmedica]

How a Quality & Regulatory training can help you? [Sofmedica]

In this episode, we will tell you why this is important to invest on trainings for your employees. I have invited a company that participated to the Green Belt Certificate and I asked them to tell us ...

23 Nov 20200s

Do you need an Expert Panel for your Medical Devices? [Bassil Akra]

Do you need an Expert Panel for your Medical Devices? [Bassil Akra]

If you thought that clinical evaluation was already difficult to work on with the new EU MDR, then listen to this episode where we will tell you about the new level of difficulty that is coming soon. ...

16 Nov 20200s

What are Common Specifications under EU MDR & IVDR?

What are Common Specifications under EU MDR & IVDR?

Common Specifications are a type of regulation that we will explain to you in this episode with Stefan Bolleininger. The one on Reusable single use device was published. We expect more to come. The po...

9 Nov 20200s

We’ve reached episode 100 – What happened for the last 2 years?

We’ve reached episode 100 – What happened for the last 2 years?

We have reached 100 episodes on the podcast and today we will celebrate that. Here is an episode with some of the great influencers in the Medical Device field which are sharing with us their journey....

2 Nov 20200s

How to certify a self-testing device under IVDR? [Erik Vollebregt]

How to certify a self-testing device under IVDR? [Erik Vollebregt]

Self-testing devices are already existing in the market and already mentioned under IVDD. But what does change with the new IVDR? Erik Vollebregt from Axon Lawyers will help us to interpret that. The ...

26 Okt 20200s

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