MDSAP Audit Approach (MDSAP AU P0002) C5-T3-T4: Plan and control each design and development project, with stages, reviews, verification, validation, transfer, responsibilities and interfaces, under established procedures

What does C5-T3-T4 require?

Design and development must be planned and controlled: the plan should set out stages, the review, verification, validation and transfer activities for each stage, and the responsibilities, authorities and interfaces between groups, and the design procedures (covering stages, review, verification, validation, transfer and changes) must be established and applied to the project. Australia: design planning must be documented, typically in a quality plan (Sch 3 Pt 1 cl 1.4(4)). Canada: manufacturers of Class IV devices must keep a quality plan setting out its particular quality practices, resources and the order of activities (CMDR 32). Clauses: ISO 13485:2016 4.2.1, 7.1, 7.3.1, 7.3.2, 7.3.10; RDC 665/2022 Arts 43, 44, 61; MO169 Arts 6, 26, 30, 36-2.