MDR 2017/745
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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 on EUDAMED. But EUDAMED is not complete for the moment, so should we rush? When will this been mandatory? Let’s review that together.
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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, […]
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Interviews on Being The PRRC
Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different […]
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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
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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 method. But what can be some traps to that? Let’s listen to Enrico Allegra from TestLabs to understand how you can do this action in a safe mode.
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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 these questions will be answered on this podcast with Cesare Magri from 4BetterDevices.
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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. For that I have invited Christophe Girardey from Wega to help move on that direction
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Hire your QA RA person with no Budget
We feel your pain when your bosses ask you to hire a QA RA person, but the challenge is that there is no Budget for it. But you want to impress them, so what to do. In this episode Mitch Robbins a professional recruiter is telling you what to do. But don’t think this will be easy.
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Who should be on your Risk Management Dream Team?
Everyone is talking about Risk Management file and ask you to provide that to them. But should you do that alone or identify the best partners on your team to be successful. This is what Naveen Agarwal from Creative Analytics Solutions LLC is sharing with us today.
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Artificial Intelligence in the Medical Device Industry
There is still this misunderstanding about AI, and we wanted to discuss about AI for Medical Devices to really understand what this is. I have invited Christophe Girardey from Wega to put some light in the dark.
