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About this document

WHO EMP RHT PQT 2019.05 Eng by Escola Beyond is a document available to read on EtoBox.

This document provides guidance for quality control of in vitro diagnostic medical devices for WHO prequalification. It outlines key concepts of quality control, quality assurance, and quality management systems. The guidance is intended for manufacturers seeking WHO prequalification and applies to all eligible in vitro diagnostic devices. Quality control processes should incorporate risk management, monitoring and measurement of products, and design change reviews. Standards, reference materials, and refer

Author
Escola Beyond
Language
EN