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A Case Study on Software Risk Analysis in Medical Device Development

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Author

Editor

  • Stefan Biffl
  • Dietmar Winkler
  • Johannes Bergmanns

Summary, in English

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.

Publishing year

2012

Language

English

Pages

143-158

Publication/Series

Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing

Volume

94

Document type

Conference paper

Publisher

Springer

Topic

  • Computer Science

Conference name

4th International Conference on Software Quality Days, SWQD 2012

Conference date

2012-01-17

Conference place

Vienna, Austria

Status

Published

ISBN/ISSN/Other

  • ISSN: 1865-1348
  • ISBN: 978-3-642-27212-7