Medical Device Software Verification, Validation, and Compliance
Vogel Publisher: Artech House. In the FDA released unofficial guidelines for manufacturers whose medical devices incorporate software, in their General Principles of Software Validation. Formal methods, which use mathematically based techniques to specify, develop, and verify software, have often failed to meet expectations when applied to the development of commercial products. Verification and Validation — what is their contribution to medical device software development? But that is starting to change, thanks to a new generation of tools.