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Verification & validation in medi spice

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Show simple item record Sivakumar, M.S. Casey, Valentine Mc Caffery, Fergal Coleman, Gerry 2011-12-15T10:21:22Z 2011-12-15T10:21:22Z 2011
dc.description non-peer-reviewed en_US
dc.description.abstract Effective verification and validation are central to medical device software de-velopment and are essential for regulatory approval. Although guidance is available in mul-tiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain en_US
dc.language.iso eng en_US
dc.relation.ispartofseries 11th International SPICE Conference on Process Improvement and Capability dEtermination;05/2011
dc.subject medical device standards en_US
dc.subject medical devices software verification and validation en_US
dc.subject medical device software process assessment and improvement en_US
dc.title Verification & validation in medi spice 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.type.restriction none en
dc.contributor.sponsor SFI
dc.relation.projectid 07/SK/I1299
dc.relation.projectid 08/IN.1/I2030

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