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Medical device software traceability.

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dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Casey, Valentine
dc.contributor.author Sivakumar, M.S.
dc.contributor.author Coleman, Gerry
dc.contributor.author Donnelly, Peter
dc.contributor.author Burton, John
dc.date.accessioned 2012-03-13T13:18:32Z
dc.date.available 2012-03-13T13:18:32Z
dc.date.issued 2012
dc.identifier.uri http://hdl.handle.net/10344/2083
dc.description peer-reviewed en_US
dc.description.abstract Software traceability is central to medical device software develop-ment and essential for regulatory approval. In order to comply with the regulatory requirements of the medical device industry it is essential to have clear linkages and traceability from requirements - including risks - through the different stages of the software development and maintenance lifecycles. The regulatory bodies request that medical device software development organizations clearly demon-strate how they follow a software development lifecycle without mandating a par-ticular lifecycle. However, due to the traceability requirements of the industry most medical device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to medical device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also de-scribes the development and implementation of a medical device traceability soft-ware process assessment method (Med-Trace) in two medical device software de-velopment organizations. We include these two case studies as one involved a medical device SME based in Ireland and the other a medical device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries. en_US
dc.language.iso eng en_US
dc.publisher Springer Verlag en_US
dc.relation.ispartofseries Software and Systems Traceability;4 pp. 321-339
dc.relation.uri http://dx.doi.org/ 10.1007/978-1-4471-2239-5_15
dc.rights The original publication is available at www.springerlink.com en_US
dc.subject medical device standards en_US
dc.subject medical device en_US
dc.subject software traceability en_US
dc.title Medical device software traceability. en_US
dc.type Book chapter 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 EC
dc.relation.projectid 07/SK/I1299
dc.relation.projectid 08/IN.1/I2030
dc.relation.projectid 100022 (CHARTER)

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