Software Validation Procedure | ISO 13485 | FDA QMSR

The Software Validation Procedure covers computer systems and software used in medical device development, production, testing, inspection and quality activities. It includes a validation protocol with instructions for planning and executing validation, documenting results and preparing a report.

Supplied as an editable Microsoft Word document as a digital download.

Production and quality-system software validation

The procedure uses a risk-based approach to determine validation effort and addresses reassessment or revalidation after relevant changes. Adapt the protocol to the software's intended use and your organization's processes.

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.

This procedure addresses validation of software used in development, production and quality activities. For the lifecycle of software that is itself the medical device, see the SaMD Development Procedure.

Compare complete A.P. Lyon QMS packages

Practical guide

Read Medical Device Software: Development, Validation and Clinical Evidence for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in Medical Device Software Procedure Bundle. Explore the bundle for the related documents.