MDSAP Audit Approach (MDSAP AU P0002) C5-T10-T11: Validate the design for the intended use with testing scaled to risk, and perform the clinical evaluation or safety and performance evaluation each jurisdiction requires

What does C5-T10-T11 require?

Design validation data must demonstrate that the approved design fulfils the requirements of its specified application or intended use, with the validation effort tuned to the kind of product and its risk, and clinical evaluations or evaluations of safety and performance must form part of validation where national or regional rules require them. Australia: validation records must include clinical evidence under the clinical evidence procedures (Sch 3 Pt 1 cl 1.4(5)(c)(vii) and Sch 3 Pt 8; Reg 3.11; EP 14), for which the TGA's clinical evidence guidelines are the reference. Clauses: ISO 13485:2016 4.2.1, 7.3.7; CMDR 12, 18, 19; RDC 665/2022 Arts 49, 53 to 58, 61 and RDC 848/2024; MO169 Arts 6, 35-1.