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

MDSAP Audit Approach (MDSAP AU P0002) C5-T14-T15: Hold design reviews at planned stages with the right functions and specialists, and review design changes for their effect on product already made and delivered

What does C5-T14-T15 require?

Design reviews must take place at suitable stages under the design plan, with participants from the functions concerned with the stage and any specialists needed, and results recorded. Design changes must be reviewed for their effect on constituent parts and on product already made and delivered, with the results kept. Clauses: ISO 13485:2016 7.3.2, 7.3.5, 7.3.9; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(c)(i); RDC 665/2022 Arts 50, 60, 61; MO169 Arts 6, 30, 33, 36-1.

Maintained by Gerard Blokdyk

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