Verification & validation in medi spice

dc.contributor.author	Sivakumar, M.S.
dc.contributor.author	Casey, Valentine
dc.contributor.author	Mc Caffery, Fergal
dc.contributor.author	Coleman, Gerry
dc.date.accessioned	2011-12-15T10:21:22Z
dc.date.available	2011-12-15T10:21:22Z
dc.date.issued	2011
dc.identifier.uri	http://hdl.handle.net/10344/1708
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