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An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

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dc.contributor.author Mc Hugh, Martin
dc.contributor.author Cawley, Oisín
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Richardson, Ita
dc.contributor.author Wang, Xiaofeng
dc.date.accessioned 2013-08-09T11:46:21Z
dc.date.available 2013-08-09T11:46:21Z
dc.date.issued 2013
dc.identifier.uri http://hdl.handle.net/10344/3300
dc.description peer-reviewed en_US
dc.description.abstract Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software. en_US
dc.language.iso eng en_US
dc.subject medical device software en_US
dc.subject safety critical en_US
dc.subject V model en_US
dc.subject agile en_US
dc.subject FDA en_US
dc.subject AV-model en_US
dc.title An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles 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.relation.projectid 08/IN.1/I2030 en_US
dc.relation.projectid 10/CE/I1855 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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