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Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle

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dc.contributor.author Mc Hugh, Martin
dc.contributor.author Mc Caffery, Fergal
dc.date.accessioned 2013-07-02T11:07:07Z
dc.date.available 2013-07-02T11:07:07Z
dc.date.issued 2013
dc.identifier.uri http://hdl.handle.net/10344/3207
dc.description peer-reviewed en_US
dc.description.abstract Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews. en_US
dc.language.iso eng en_US
dc.publisher EuroSPI 2013 en_US
dc.relation.ispartofseries EuroSPI;
dc.subject medical device en_US
dc.subject FDA en_US
dc.subject agile en_US
dc.subject software development life cycle en_US
dc.subject semi-structured interview en_US
dc.title Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle 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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