Performance Evaluation Report (PER) | IVDR PER - MakroCare
vistaarai
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vistaarai
Ongoing, First published Jun 28
clinicalresearchclinicaltrailsinvitrodaignosticsmakrocaremedicaldevicesperformanceevalution
From IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP), as well as a file of clinical evidence should be combined as a performance evaluation report (PER).
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clinicalresearchclinicaltrailsinvitrodaignosticsmakrocaremedicaldevicesperformanceevalution
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The Virus Within: The Unranked (Book 4)

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