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AUDITORS’ ORATORY: It’s all about communication as EU unannounced audits turn commercial relations into marriages

This article was originally published in Clinica

Executive Summary

The days when an intermittent update between medical device manufacturers and notified bodies in the EU was sufficient are over. In the new era of unannounced audits, it is more important now than ever for manufacturers to invest in a timely, pertinent and ongoing communication with their notified bodies. In this first instalment of Auditors Oratory, a new Clinica column that gives valuable insight into the workings of notified bodies, Chris Jepson* shares his experience at UK notified body SGS and explains why medtech industry needs to heed this advice to avoid additional expense, regulatory problems and - in extreme cases - loss of certification and ability to trade in the EU





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