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Preparing for unannounced medical device inspections in the EU - are you ready?

This article was originally published in SRA

Executive Summary

Unannounced visits from notified bodies are going to be part of life for medical device manufacturers in the EU. Inspectors arriving unannounced will expect a manufacturer to free up staff to host the visit and make available testing equipment dedicated for their immediate use. There will also be cost implications for device makers. Gert Bos and Françoise Schlemmer explain why it is critical that manufacturers and subcontractors practise and validate protocols for hosting such visits.

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