Design Review Procedure | ISO 13485 | FDA QMSR

Plan and document independent reviews at key medical device design milestones with this editable ISO 13485 Design Review Procedure and forms. It guides preparation, cross-functional assessment, decisions, action ownership and approval from feasibility and design inputs through verification, validation and launch.

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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.

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.

Reviews at meaningful design milestones

The Design Review Procedure identifies planned reviews from feasibility and design-input freeze through verification, validation and launch. Review inputs may include customer needs, specifications, risk analysis, prototypes, test reports, regulatory strategy and unresolved actions.

Independent challenge and documented action

A facilitator coordinates the review and independent assessors challenge assumptions. Minutes record decisions, action owners and approvals, giving the team evidence that the design was assessed before moving to the next phase.

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.

Use the review forms within the broader Design Control Procedure and alongside the Design Verification and Validation Procedure.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Design Controls: Requirements, Reviews and Transfer for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Design Control Procedure Bundle. Explore the bundle for the related documents.