Standard Document
First Edition
ISO
ISO20916
In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
This document outlines best practices for planning, designing, conducting, recording, and reporting clinical performance studies of in vitro diagnostic (IVD) medical devices. It ensures a reliable assessment of clinical performance and safety for regulatory compliance, supporting manufacturers in meeting industry standards.
May 01, 2019
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Product Details
ISO20916E
56