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Med-Trace: traceability assessment method for medical device software development

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dc.contributor.author Casey, Valentine
dc.contributor.author Mc Caffery, Fergal
dc.date.accessioned 2011-12-21T13:52:51Z
dc.date.available 2011-12-21T13:52:51Z
dc.date.issued 2011
dc.identifier.uri http://hdl.handle.net/10344/1746
dc.description peer-reviewed en_US
dc.description.abstract Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments. en_US
dc.language.iso eng en_US
dc.relation.ispartofseries European Systems and Software Process Imporvement and Innovation Conference EuroSP1;2011
dc.subject medical device standards en_US
dc.subject medical device software en_US
dc.title Med-Trace: traceability assessment method for medical device software development en_US
dc.type Conference item en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.type.restriction none en
dc.contributor.sponsor SFI
dc.contributor.sponsor IGERDF
dc.contributor.sponsor ISERC
dc.relation.projectid 07/SKI1299
dc.relation.projectid 08/IN.1I2030
dc.relation.projectid 03/CE2I303_1
dc.internal.authorcontactother val.casey@dkit.ie
dc.internal.authorcontactother fergal.mccaffery@dkit.ie


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