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A traceability process assessment model for the medical device domain

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dc.contributor.author Regan, Gilbert
dc.contributor.author Biro, Miklos
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author McDaid, Kevin
dc.contributor.author Flood, Derek
dc.date.accessioned 2015-03-30T13:18:36Z
dc.date.issued 2014
dc.identifier.uri http://hdl.handle.net/10344/4389
dc.description peer-reviewed en_US
dc.description.abstract Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as im-pact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, as in other safety critical domains, soft-ware must provide reliability, safety and security because failure to do so can lead to injury or death. However, despite its criticality most software systems don’t employ explicit traceability between artefacts. Numerous barriers hamper the effective implementation of traceability such as cost, complexity of relation-ship between artefacts, calculating a return on investment, different stakeholder viewpoints, lack of awareness of traceability and a lack of guidance as to how to implement traceability. To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the devel-opment of a traceability process assessment model and how traceability process assessment and maintenance could be fully automated using the Open Services for Lifecycle Collaboration (OSLC) initiative. The process assessment model will allow organisations to identify strengths and weaknesses in their existing traceability process and pinpoint areas for improvement. en_US
dc.language.iso eng en_US
dc.publisher Springer en_US
dc.relation.ispartofseries EuroSPI 2014 [Communications in Computer and Information Science ];425, pp. 206-216
dc.relation.uri http://link.springer.com/book/10.1007%2F978-3-662-43896-1
dc.rights The original publication is available at www.springerlink.com en_US
dc.subject requirements traceability en_US
dc.subject traceability assessment en_US
dc.subject medical device en_US
dc.subject safety critical en_US
dc.subject process assessment en_US
dc.subject automation en_US
dc.title A traceability process assessment model for the medical device domain 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.identifier.doi 10.1007/978-3-662-43896-1_18
dc.contributor.sponsor SFI en_US
dc.relation.projectid 07/SK/I1299 en_US
dc.relation.projectid 08/IN.12030 en_US
dc.relation.projectid 10/CE/11855 en_US
dc.date.embargoEndDate 2015-06-27
dc.embargo.terms 2015-06-27 en_US
dc.rights.accessrights info:eu-repo/semantics/embargoedAccess en_US


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