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A Case Study on Sof...
A Case Study on Software Risk Analysis 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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Biffl, Stefan (redaktör/utgivare)
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Winkler, Dietmar (redaktör/utgivare)
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Bergmanns, Johannes (redaktör/utgivare)
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(creator_code:org_t)
- Berlin, Heidelberg : Springer Berlin Heidelberg, 2012
- 2012
- Engelska.
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Ingår i: Software Quality. Process Automation in Software Development/Lecture Notes in Business Information Processing. - Berlin, Heidelberg : Springer Berlin Heidelberg. - 1865-1348. - 9783642272127 ; 94, s. 143-158
- Relaterad länk:
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http://dx.doi.org/10...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- NATURVETENSKAP -- Data- och informationsvetenskap -- Datavetenskap (hsv//swe)
- NATURAL SCIENCES -- Computer and Information Sciences -- Computer Sciences (hsv//eng)
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