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Post-Marketing Clinical Follow-up with Helene Quie (PMCF)
PMCF or Post-Marketing Clinical Follow-Up is a cornerstone of the Medical Device Regulation 2017/745.
This is why I took the opportunity to ask some questions about it to Helene Quie from Qmed Consulting. I met Helene at Medica 2019 in Dusseldorf and she accepted to help the audience to have a better understanding of PMCF.
Helene was part of the podcast episode 40 where we discussed Clinical Evaluation Reports or CER and specifically about the way to prove the equivalence between devices.
PMCF is part of this big box that is PMS or Post-Market Surveillance and this can be a good strategy to…
The skinny
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