Module 14: Design Development and Certification of Medical Devices

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22/11/2023

Inspection Information – why is this asked for? • Incoming, in-process & final inspection checks & the results (Annex VII 4.5.3) • Common question – “Why is this being requested outside the QMS audit?” • MDR requires that the NB review this as part of the Annex IX technical documentation assessment (not only QMS audits)

The Organisation for Professionals in Regulatory Affairs

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Improving Technical Documentation Submissions

The Organisation for Professionals in Regulatory Affairs

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