Demonstration of Clinical Performance as per IVDR | HCLTech

Demonstration of Clinical Performance as per IVDR

This Whitepaper focuses on the new requirements of IVDR on Clinical performance described in "Annex XIII, Part A, Section 1.2.3 - Demonstration of the clinical performance". It necessitates the manufacturer to go through the existing evidence and ensure that it is in compliance with the new definitions and clinical performance requirements set by IVDR. HCLTech developed its own process flow to comply with the new requirements and provides the support to complete clinical performance reports for Invitro diagnostic medical devices as per new EU IVDR regulations. The paper discusses about the technical difficulties and possible way of resolving them in relation to the Clinical performance report requirements. Download this whitepaper to know more.

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