Software validation

It is part of design validation of the whole device, not only a software test phase. Verification asks whether each development stage met its inputs, while validation asks whether the finished software does the right job for its users.

For the purposes of this guidance, software validation refers to establishing, by objective evidence, that the software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled. Software validation is a part of design validation of the finished device. It involves checking for proper operation of the software in its actual or simulated use environment, including integration into the final device where appropriate. Software validation is highly dependent upon comprehensive software testing and other verification tasks previously completed at each stage of the software development life cycle. Planning, requirements, traceability, testing, risk assessment, design reviews, change management, and many other aspects of good software engineering are important activities that together help to support a conclusion that software is validated.

FDA guidance: Content of Premarket Submissions for Device Software Functions (June 2023), Section IV, Definitions