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A case study on sof...
A case study on software risk analysis and planning in medical device development
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- Lindholm, Christin (författare)
- Lund University,Lunds universitet,Institutionen för datavetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Department of Computer Science,Departments at LTH,Faculty of Engineering, LTH
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- Holmén Notander, Jesper (författare)
- Lund University,Lunds universitet,Institutionen för datavetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Department of Computer Science,Departments at LTH,Faculty of Engineering, LTH
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- Höst, Martin (författare)
- Lund University,Lunds universitet,Institutionen för datavetenskap,Institutioner vid LTH,Lunds Tekniska Högskola,Department of Computer Science,Departments at LTH,Faculty of Engineering, LTH
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(creator_code:org_t)
- 2013-10-02
- 2014
- Engelska.
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Ingår i: Software Quality Journal. - : Springer Science and Business Media LLC. - 0963-9314 .- 1573-1367. ; 22:3, s. 469-497
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Abstract
Ämnesord
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- Software failures in medical devices can lead to catastrophic situations. Therefore, it is crucial to handle software-related risks when developing medical devices, and there is a need for further analysis of how this type of risk management should be conducted. The objective of this paper is to collect and summarise experiences from conducting risk management with an organisation developing medical devices. Specific focus is put on the first steps of the risk management process, i.e. risk identification, risk analysis, and risk planning. 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. First, the method was defined based on already available methods and then used. The defined method focuses on user risks, based on scenarios describing the expected use of the medical device in its target environment. During the use of the method, different stakeholders, including intended users, were involved. Results from the case study show that there are challenging problems 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, estimation of detectability during risk analysis, and action proposals during risk planning. It can be concluded that the risk management method has potential to be used in the development organisation, although future research is needed with respect to, for example, context limitation and how to allow for flexible updates of the product.
Ämnesord
- NATURVETENSKAP -- Data- och informationsvetenskap -- Datavetenskap (hsv//swe)
- NATURAL SCIENCES -- Computer and Information Sciences -- Computer Sciences (hsv//eng)
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