Software Validation Procedure | ISO 13485 | FDA QMSR

The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The procedure includes a detailed validation protocol with step by step instruction for conducting the validation and generating a validation report.

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ISO 13485:2016 Software Validation Procedure

The Software Validation Procedure governs computer systems and medical device software used in medical device development, production and QA activities. The protocol, included with the procedure, can be applied to the validation of computer systems, software used in medical device development, production, testing and inspection activities, and more to ensure each has been validated for their intended use.

ISO 13485:2016 Software Validation Procedure Overview

The Software Validation Procedure uses a risk based approach for conducting software validations. The validation protocol included with the procedure provides step by step instruction through the entire validation process. The procedure also provides instruction on the content and structure of validation reports.

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.