№ lp_1_2_55857
This document outlines the assessment and decision process for the recognition of Auditing Organizations under the Medical Device Single Audit Program (MDSAP), detailing the grading and management of nonconformities, as well as the outcomes of assessments.
Year: 2021
Region / City: International
Topic: Medical Device Regulation, Auditing
Document Type: Final Document
Organization / Institution: International Medical Device Regulators Forum (IMDRF)
Author: IMDRF MDSAP Working Group
Target Audience: Regulatory Authorities, Auditing Organizations
Effective Period: Not specified
Approval Date: 16 September 2021
Revision Date: Not specified
Price: 8 / 10 USD
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