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Asian industry set to get new QMS auditing and post-market safety guidelines

This article was originally published in Clinica

Executive Summary

The Asian Harmonization Working Party (AHWP) has set out new guidelines which it wants its member countries to use when auditing the quality management systems (QMS) of medical device manufacturers. They were formally presented for endorsement at its annual conference last week, together with another two documents that aim to establish uniform standards for overseeing the safety of marketed medical devices and the reporting of adverse events.

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