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A Case Study on Software Risk Analysis in Medical Device Development

  • Stefan Biffl
  • Dietmar Winkler
  • Johannes Bergmanns
Publiceringsår: 2012
Språk: Engelska
Sidor: 143-158
Publikation/Tidskrift/Serie: Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing
Volym: 94
Dokumenttyp: Konferensbidrag
Förlag: Springer


Software failures in medical devices can lead to catastrophic situations. Therefore is it crucial to handle software related risks when developing medical devices. This paper presents the experiences gained from an ongoing case study with a medical device development organisation. This part of the study focuses on the two first steps of the risk management process, i.e. risk identification and risk analysis. The research is conducted as action research, with the aim of analysing and giving input to the organisation’s introduction of a software risk management process. The risk identification activities focus on user risks based on scenarios describing the expected use of the medical device in its target environment. Challenging problems have been found in the risk management process with respect to definition of the system boundary and system context, the use of scenarios as input to the risk identification and estimation of detectability used during risk assessment.


  • Computer Science


4th International Conference on Software Quality Days, SWQD 2012
  • Software Engineering-lup-obsolete
  • ISSN: 1865-1348
  • ISBN: 978-3-642-27212-7

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