Under what circumstances are PMCF surveys the solution?

When thinking about PMCF surveys, it is a good idea to think about the clinical evidence, CER, history of the device from a post-market side as well to identify the areas of gaps and the areas where the device can be improved and then think through whether or not a survey would address those needs.

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There are 3 rounds of questions, but if the NB brings in a new expert during the review (clinical, for example), will that additional reviewer have his/her own 3 rounds of questions?

Video FAQ

What are examples of inadequate PMCF data resulting in audit findings in MDD or MDR audits?

Video FAQ

Can we use PMCF to fill current clinical evidence gaps?
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