Sound Verification Techniques for Developing High-Integrity Medical Device Software

Embedded software in medical devices is increasing in content and complexity. Traditional software verification and testing methods may not provide the optimum solution. This paper discusses the application of sound verification techniques in the development of high integrity medical device software. Specifically, this paper will explore the application of formal methods based Abstract Interpretation techniques to mathematically prove the absence of a defined set of run-time errors. The verification solution is then compared and contrasted to other software analysis and testing methods, such as code review, static analysis and dynamic testing.