MDSAP Audit Approach (MDSAP AU P0002)
Chapter 5: Design and development – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C5-T16: Transfer the design correctly to production, releasing it only after authorised review of the complete design history

What does C5-T16 require?

The organisation must transfer the design correctly into production methods and procedures. Brazil: the design must not be released to production until the designated people approve it, after reviewing every record required in the design history file confirming the file is complete and the final design is consistent with the approved plans, with the release, date and signature documented (RDC 665/2022 Arts 58, 61). Clauses: ISO 13485:2016 4.2.1, 4.2.3, 7.3.8; RDC 665/2022 Arts 52, 54 to 58, 61; MO169 Arts 6, 7-2, 35-2.

Maintained by Gerard Blokdyk

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