Design Verification - Validation Procedure | ISO 13485 | FDA QMSR

Plan and document medical device design verification and validation with this editable procedure. It separates evidence that design outputs meet approved inputs from evidence that the finished device meets user needs and intended uses. The procedure addresses protocols, acceptance criteria, recorded results, deviations and review within the design and development process.

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Supplied as one editable Microsoft Word document in a digital download.

Design Verification and Validation Procedure

The Design Verification and Validation Procedure defines the design verification and validation activity conducted as part of medical device product development projects in accordance with FDA QMSR and ISO 13485:2016.

The Design Verification and Validation Procedure addresses the design verification and validation elements of the design and development cycle. Design Verification examines and provides objective evidence that the specified requirements of a product design have been fulfilled. Whereas, Design Validation establishes by objective evidence that device specifications conform with user needs and intended uses.

Verification and validation are separate decisions

The procedure describes verification as objective evidence that design outputs meet approved design inputs. Validation assesses whether the resulting device meets user needs and intended uses, with planned protocols, acceptance criteria, recorded results and review of deviations.

Evidence and interfaces

It addresses product performance testing, software verification or validation where applicable, and the relationship to manufacturing process qualification. The project team maintains the resulting evidence in the development record and resolves failures before approval.

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.

Related stage decisions are documented with the Design Review Procedure; completed design evidence feeds the Design Transfer Procedure.

When the device requires a biological evaluation as part of development evidence, see the separately sold Biocompatibility and Toxicity Testing Procedure for an evaluation workflow and sample documentation.

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.