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Unannounced audits signal a new, much tougher era for EU medtech sector

This article was originally published in SRA

Executive Summary

There has been a largely negative response from the medtech industry to unannounced audits by notified bodies in the EU. But what is perspective from the other side? What is it like for notified bodies, who are under increased scrutiny from their designating authorities and under pressure to deliver far more stringent auditing of medtech manufacturers. Reporting from regulatory meetings in Brussels, Berlin and London, Amanda Maxwell provides a snapshot of the mood,




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