Medical Device made Easy Podcast

Medical Device made Easy Podcast

Listen Medical Device Regulation and Standards

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Episoder(405)

What are some pitfalls to avoid during Software Design?

What are some pitfalls to avoid during Software Design?

When we develop a Software, there are some pitfalls that you can avoid. Weronika Michaluk from HTD Health will explain to us how to do that. Don’t miss this to accelerate your development and avoid to...

10 Okt 20230s

October 2023 Regulatory Update

October 2023 Regulatory Update

MEDICAL DEVICE NEWS October 2023 Regulatory Update The post October 2023 Regulatory Update appeared first on Medical Device made Easy Podcast. hamza benafqir

4 Okt 20230s

What is the EUDAMED Updates?

What is the EUDAMED Updates?

In this episode, Richard Houlihan will explain to us the current situation about EUDAMED. This is the new European Database for Medical Devices and a lot of people are asking to start the registration...

26 Sep 20230s

Interviews on Being The PRRC (Part 2)

Interviews on Being The PRRC (Part 2)

In this second part of this podcast series on Team-Prrc interviews. we have 3 additional guests. Don’t miss the first one where we also got great interviews. In this episode, […] The post Interviews o...

19 Sep 20230s

MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulatory Update

This month we will review all what happened in the Medical Device world during the last weeks and what will happen in the next weeks. Check that The post MEDICAL DEVICE NEWS – SEPTEMBER 2023 Regulator...

6 Sep 20230s

How to perform your Cleaning Validation in practice?

How to perform your Cleaning Validation in practice?

If your Medical Device needs to be cleaned then it means that you need to prove that the cleaning method you propose is working. So how to do that? A laboratory can help for this by testing your metho...

29 Aug 20230s

What are the Acceptance Criteria for your Clinical Evaluation?

What are the Acceptance Criteria for your Clinical Evaluation?

We all want to follow EU MDR 2017/745 but for that you need to have clinical data and a clinical evaluation. But what are the acceptance criteria for it? Who defines the rules? Can this evolve? All th...

22 Aug 20230s

Why you should automate your Software validation?

Why you should automate your Software validation?

Did you had this blank in your head when an auditor asked you the validation documents of your software? I know your pain. So today we will try to help you validate your software with some automation....

15 Aug 20230s

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