Involving user perspective in a software risk management process

Research output: Contribution to journalArticlepeer-review


More and more user groups are using medical devices. Heart starters are, for example, available in public
places and used by non-professionals. Different mobile medical applications, designed to help people
manage their own health, are now being added to the medical device spectra. Users handling medical
devices make errors, but by involving users in the risk management process, it is possible to lower the risk
of these errors. This paper presents an evaluation of the value of complementing a traditional risk management
process with an emphasised user perspective. A medical device software risk management framework
is being designed, and the risk management process should be regarded as the first part of the framework.
The main goal of the evaluated risk management process is to integrate users and user perspective into
the risk management process. The results indicate that the use of use cases as input at risk meetings makes
the discussions more focused, saving effort and time. When users attend the risk meetings, user perspective
and domain knowledge are brought into the process, affecting risk identification and risk assessment.
The results also show that the use of usability testing gives valuable input to the risk management process.
Original languageEnglish
Pages (from-to)953-975
JournalJournal of software: Evolution and Process
Issue number12
Publication statusPublished - 2015

Subject classification (UKÄ)

  • Computer Systems

Free keywords

  • risk management
  • user perspective
  • medical device development
  • software development
  • usability testing


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