Looking for the basics of #VDR? Check out this summary of IVDR and contact us to discuss your tailored needs.
Evnia will help you prepare your performance evaluation PEP & PER after a thorough discussion and assessment of your
– QMS alignment
– Reclassification rationale
– PMS data (as per Art. 78, including your Post-Market Performance Follow-up (PMPF) activities and required PSUR updates)
-Comprehensiveness of vigilance data as per Art.82
-Sufficiency of available clinical data and the need to obtain new/more
-Availability of Notified Body and potential migration
-Conformity assessment procedure
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