MDSAP Audit Approach (MDSAP AU P0002) C6-T1: Plan product realization with the controls, controlled conditions and risk management needed to meet intended use and regulatory requirements, consistent with the rest of the QMS and the quality objectives

What does C6-T1 require?

Product realization processes must be planned, including the controls, controlled conditions and risk management needed for the product to meet its specified or intended use and the statutory and regulatory requirements, and the planning must fit the other QMS processes and the quality objectives. For devices with software or programmable logic (US), the manufacturer must document a security risk assessment that finds and manages risks to patient safety (ISO 13485:2016 7.1). Clauses: ISO 13485:2016 4.2.1, 7.1, 7.2.1, 7.5.1; TG(MD)R Sch 1 Pt 1 EP 2, Sch 3 Pt 1 cl 1.4(4) and (5)(d)(e); RDC 665/2022 Arts 5 to 7, 44, 52, 64 to 66; MO169 Arts 26, 27, 40; 21 CFR 801, 820.10(b)(1), 830.