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Software risk analysis in medical device development

  • Stefan Biffel
  • Mika Koivuluoma
  • Pekka Abrahamsson
  • Markku Oivo
Publiceringsår: 2011
Språk: Engelska
Sidor: 362-365
Publikation/Tidskrift/Serie: Proceedings of the 37th EUROMICRO Conference on Software Engineering and Advanced Applications
Dokumenttyp: Konferensbidrag
Förlag: IEEE--Institute of Electrical and Electronics Engineers Inc.


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.


  • Computer Science
  • risk management
  • risk analysis
  • software development
  • medical device development


EUROMICRO Conference on Software Engineering and Advanced Applications
  • Software Engineering-lup-obsolete
  • ISBN: 978-0-7695-4488-5

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