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Does the MDSAP add requirements for the manufacturer?
The MDSAP Audit Approach was created to reflect the existing requirements of the RAs involved in MDSAP. It does not introduce any new requirements beyond those in ISO 13485 or specific national regulations. This document is intended for use by AOs, not manufacturers. Manufacturers must continue to meet all applicable regulatory requirements. Auditors use the MDSAP Audit Approach to systematically assess compliance to applicable regulatory requirements.
Contractual agreements between a manufacturer and its AO may however include specificterms to enable them to effectively perform their duties under the program.