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Improving software risk management in a medical device company

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dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Burton, John
dc.contributor.author Richardson, Ita
dc.date.accessioned 2012-06-26T15:53:26Z
dc.date.available 2012-06-26T15:53:26Z
dc.date.issued 2009
dc.identifier.citation McCaffery, F et al (2009) "Improving software risk management in a medical device company," in 31st International Conference on Software Engineering, ICSE 2009 (Software Engineering in Practice Track en_US
dc.identifier.uri http://hdl.handle.net/10344/2294
dc.description peer-reviewed en_US
dc.description.abstract Software Risk Management (RM) within Medical Device (MD) companies is a critical area. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. Therefore regulators penalise MD manufacturers that do not devote sufficient attention to the areas of hazard analysis and RM throughout the software lifecycle. This paper describes the experience of a MD software development organization when they engaged in a research project to improve their RM practices. We explain how this was achieved through the development of a software process improvement RM model that integrates regulatory MD RM requirements with the goals and practices of the Capability Maturity Model Integration (CMMI). This model is known as the Risk Management Capability Model (RMCM). The authors describe the complete project lifecycle and evaluate the success of the project. en_US
dc.language.iso eng en_US
dc.publisher IEEE Computer Society en_US
dc.relation.ispartofseries 31st International Conference on Software Engineering, ICSE 2009 (Software Engineering in Practice Track;
dc.relation.uri http://dx.doi.org/ 10.1109/ICSE-COMPANION.2009.5070973
dc.rights “© 2009 IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other uses, in any current or future media, including reprinting/republishing this material for advertising or promotional purposes, creating new collective works, for resale or redistribution to servers or lists, or reuse of any copyrighted component of this work in other works en_US
dc.subject capability maturity model en_US
dc.subject biomedical equipment en_US
dc.subject hazards risk management en_US
dc.title Improving software risk management in a medical device company en_US
dc.type info:eu-repo/semantics/conferenceObject en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.contributor.sponsor SFI en_US
dc.relation.projectid 07/SK/I1299 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US

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