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 |