Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

PMS & PMPF flow-chart

Performance Evaluation Procedure

Performance Evaluation Plan (PEP)

Analytical Performance

Scientific Validity

Clinical Performance

SV method

AP Protocol

CP Study Plan

SV Report

AP Report

CP Study Report

Performance Evaluation Report (PER)

PMS Process

Procedure

Report

PMPF Evaluation Report

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