Design Analysis Procedure | ISO 13485 | FDA QMSR

The Design Analysis Procedure helps medical device teams examine product and process risks during development and when significant changes are proposed. It describes DFMECA, PFMECA, House of Quality (HOQ) and Fault Tree Analysis (FTA), including the role of each method in identifying failures and considering controls.

Teams can review the analyses alongside design inputs, specifications and verification evidence. The records provide a rationale for design decisions, further testing and risk-control work under the organization's risk-management process.

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.

Supplied as editable Microsoft Word documents with related forms as a digital download.

Part of a procedure bundle

This document is also included in Risk Management Procedures Bundle. Explore the bundle for the related documents.

Related design and risk work

Use the Risk Management Procedure for the broader risk process and the Design Change Procedure when a proposed modification calls for renewed analysis. These are separately sold procedures; Design Analysis is also included in the Risk Management Procedures Bundle described above.