Design Review Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Design Review Procedure establishes the systematic review of medical device development projects at logical points in the design process. The ISO 13485:2016 Design Review Procedure includes detailed review forms to document the entire design review process.

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Design Review Procedure

The Design Review Procedure establishes the systematic review of medical device development projects at logical points in the design and development process.

Design Review Procedure - Overview

The Design Review Procedure is centered on the systematic review of new product design, extensions to existing lines, and design modifications requiring design control. Design Review Procedure includes review forms to document the entire review process.

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.