Software Risk Analysis in Medical Device Development

Abstract

The purpose of risk management in the development of safety-critical software is to eliminate or reduce harmful behaviour. In health-care it is essential to manage risk related to software due to its increased use in medical devices and other computer systems. This paper presents some of the experiences gained from an ongoing case study at a large hospital in Sweden. The study focuses on identification and analysis of risks using scenarios and how effective this approach is. The research is conducted as action research, with the aim of analysing and giving input to the organisation's new software risk management process.