Safety in medical device software: questions and answers (June 2011)

Summary

Software is playing an expanding role in modern medical devices, raising the question of how developers, regulators, medical professionals, and patients can be confident in the devices' reliability, safety, and security. Software- related errors in medical equipment have caused people's deaths in the past, so the issue is not simply theoretical.

Device manufacturers need to provide safety assurance for complex software that is being developed in a competitive environment where price and time-to-market are critical factors. Further, security issues that previously were not a major concern now need to be anticipated and handled.

In this interview, published by Electronic Design, Dr. Benjamin Brosgol, senior member of the technical staff at Adacore, talks about these issues.