MDSAP Audit Approach (MDSAP AU P0002) C5-T5-T6: Establish, review and approve complete, unambiguous, non-conflicting design inputs covering function, performance, safety, intended use, regulations (including Essential Principles), human factors, risk controls and known security vulnerabilities

What does C5-T5-T6 require?

Design inputs must be set, reviewed and approved, and must cover functional, performance, usability and safety requirements for the intended use, applicable regulatory requirements, human factors needs and outputs of risk management, and must be complete, unambiguous and free of conflict. Australia: inputs must identify the Essential Principles that apply, take post-production feedback and customer requirements into account, and follow safety principles drawn from the generally accepted state of the art; applying in full a standard named in a Medical Device Standards Order gives a presumption of conformity, and where relevant standards are not used the manufacturer must document why its alternatives show compliance (Sch 3 Pt 1 cl 1.4(5)(c)(iii)(C)). United States: devices distributed there need the right 510(k) clearance or PMA, and for devices with software or programmable logic the inputs must include physical and performance requirements to remove or mitigate known security vulnerabilities. Clauses: ISO 13485:2016 4.2.1, 5.2, 7.2.1, 7.3.3, 8.2.1; TG(MD)R Sch 1 Pt 1 EP 2; CMDR 10 to 23 and 66 to 68; RDC 665/2022 Arts 18 to 20, 46, 61; MO169 Arts 6, 11, 27, 31, 55-1.