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Guidance for Regulatory Authority Assessors on the Method of Assessment for MD SAP Auditing Organizations

Origin/Publisher:

IMDRF

Document Type:
Guidance
Content:
This document provides guidance on the process-based assessment method described in section 6 of the document IMDRF/MDSAP WG/N5. The assessment method specific to a particular medical device regulatory audit scheme may take into account additional requirements from the jurisdictions addressed in the scheme.

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