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Impact of standards on the role and application of traceability in the medical device domain

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dc.contributor.author Regan, Gilbert
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Mc Daid, Kevin
dc.contributor.author Flood, Derek
dc.date.accessioned 2012-09-10T15:09:22Z
dc.date.available 2012-09-10T15:09:22Z
dc.date.issued 2012
dc.identifier.uri http://hdl.handle.net/10344/2526
dc.description peer-reviewed en_US
dc.description.abstract Software failure in the medical device domain can lead to injury or death. Controlling this risk is fundamental to producing quality software. To produce quality software, an effective requirements and hazards traceability process is required. Hence traceability is central to medical device software de-velopment. It is also an essential requirement for regulatory approval. The ne-cessity for traceability is reinforced by the medical device standards and guide-lines. In this paper we outline how traceability is an important part of medical device software development, what standards contain reference to traceability, and which specific clauses within those standards companies should refer to when defining their traceability processes. We also summarise the findings ob-tained when a lightweight assessment method (Med-Trace), that we created, based upon the traceability practices within these standards, was implemented in two SME organizations. en_US
dc.language.iso eng en_US
dc.publisher EuroSPI 2012 en_US
dc.relation.ispartofseries EuroSPI;
dc.subject med-trace en_US
dc.subject medical device-standard en_US
dc.subject software traceability en_US
dc.subject software process en_US
dc.subject assessment/improvement en_US
dc.title Impact of standards on the role and application of traceability in 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.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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