Developing safety-critical software.

Abstract

The role of safety-critical software in the development of medical devices is becoming increasingly important and ever more exacting demands are being made of software developers. This article considers safety issues and a software development life-cycle based on the safety life-cycle described in IEC 1508, "Safety-Related Systems: Functional Safety." It identifies relevant standards, both emerging and published, and provides guidance on methods that could be used to meet those standards.