A software analysis technique for quantifying reliability in high-risk medical devices

摘要

The authors present a software engineering technique called sensitivity analysis that aims at producing software that is less likely to hide faults. When sensitivity analysis indicates that faults are not likely to hide from testing, they can more comfortably rely on the results of testing. Sensitivity analysis has been automated, and preliminary results from the automated analysis suggest that the technique will have significant advantages for the development, validation, and regulation of medical devices.