Advanced

A Case Study on Software Risk Analysis in Medical Device Development

Lindholm, Christin LU ; Holmén Notander, Jesper LU and Höst, Martin LU (2012) 4th International Conference on Software Quality Days, SWQD 2012 In Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing 94. p.143-158
Abstract
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Chapter in Book/Report/Conference proceeding
publication status
published
subject
in
Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing
editor
Biffl, Stefan; Winkler, Dietmar; Bergmanns, Johannes; ; and
volume
94
pages
143 - 158
publisher
Springer
conference name
4th International Conference on Software Quality Days, SWQD 2012
external identifiers
  • wos:000309982600010
  • scopus:84855913729
ISSN
1865-1348
ISBN
978-3-642-27212-7
DOI
10.1007/978-3-642-27213-4_10
language
English
LU publication?
yes
id
1c1c2536-b6af-44db-a1af-52ff4c038451 (old id 2438865)
date added to LUP
2012-04-19 13:34:23
date last changed
2017-08-13 03:57:30
@inproceedings{1c1c2536-b6af-44db-a1af-52ff4c038451,
  abstract     = {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.},
  author       = {Lindholm, Christin and Holmén Notander, Jesper and Höst, Martin},
  booktitle    = {Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing},
  editor       = {Biffl, Stefan and Winkler, Dietmar and Bergmanns, Johannes},
  isbn         = {978-3-642-27212-7},
  issn         = {1865-1348},
  language     = {eng},
  pages        = {143--158},
  publisher    = {Springer},
  title        = {A Case Study on Software Risk Analysis in Medical Device Development},
  url          = {http://dx.doi.org/10.1007/978-3-642-27213-4_10},
  volume       = {94},
  year         = {2012},
}