What means Sufficient Clinical Data with Bassil Akra (EU MDR)

What means Sufficient Clinical Data with Bassil Akra (EU MDR)

Easy Medical Device

4 года назад

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@Auronno_is_legend
@Auronno_is_legend - 30.06.2020 13:14

Hello, nice podcast and thank you for all the information.

How do you fulfill the "proactively factor" in PMCF?

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@azfarrehman3605
@azfarrehman3605 - 05.02.2021 11:18

Thank you for your great work and information.
Could you illuminate how to use equivalence data in PMCF? Since the MDR requirements have become very stict for equivalence, would it be ok to gather PMCF data for other products which are similar, if equivalence is not possible?

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