Design Analysis Procedure | ISO 13485 | FDA QMSR

The Design Analysis Procedure includes detailed guidance on how to conduct DFMECA, PFMECA, House of Quality(HOQ) and Fault Tree Analysis(FTA).

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Design Analysis Procedure

The Design Analysis Procedure is used in conjunction with the company's risk management policies applicable to the development of new products and processes; and for significant changes to existing products or processes.

ISO Design Analysis Procedure Overview

The Design Analysis Procedure includes detailed guidance on how to conduct DFMECA, PFMECA, House of Quality(HOQ) and Fault Tree Analysis(FTA). The procedure includes all related forms and ground rules for each study,

The Design Analysis Procedure is used during product development, design verification and validation activity, and helps design teams to assess and mitigate the individual and overall risk of products and related processes.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.