MDSAP Audit Approach (MDSAP AU P0002) C5-T7: Make design outputs traceable to and satisfy inputs, identify the outputs essential for proper functioning, and verify the design

What does C5-T7 require?

Device specifications must show that design outputs trace to and meet the input requirements, and outputs essential for proper functioning must be identified; outputs include device specifications, manufacturing and (where relevant) sterilisation process specifications, quality assurance testing, and labelling and packaging. Australia: where relevant standards are not applied in full, the manufacturer must document why the alternative methods show compliance with the Essential Principles, and for devices incorporating a medicinal substance the documentation must identify which test data cover the substance and how it interacts with the device (Sch 3 Pt 1 cl 1.4(5)(c)(iii)(C) and (v)). Clauses: ISO 13485:2016 4.2.1, 4.2.3, 7.3.4; RDC 665/2022 Arts 48, 49, 61 and RDC 848/2024 Art 1; MO169 Arts 6, 7-2, 32.