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Improving verification & validation in the medical device domain

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Show simple item record Sivakumar, M.S. Casey, Valentine Mc Caffery, Fergal Coleman, Gerry 2012-01-06T10:42:26Z 2012-01-06T10:42:26Z 2011
dc.description peer-reviewed en_US
dc.description.abstract The benefits of effective verification and validation activities in the medical device domain include increased usability and reliability, decreased failure rate and recalls and reduced risks to patients and users. Though there is guidance on verification and validation in multiple standards in the medical device domain, these are difficult for the manufacturer to implement, as there is no consolidated information on how they can be successfully achieved. The paper highlights three major areas for improvement in the medical device software development domain. This research is based on an analysis of available literature in the field of verification and validation in generic software development, safety-critical and medical device software domains. Additionally, we also performed a review of the standards and process improvement models available in these domains
dc.language.iso eng en_US
dc.publisher Springer en_US
dc.relation.ispartofseries European Systems and Software Process Improvement and Innovation Conference (Euro SPI);06/2011
dc.rights The original publication is available at en_US
dc.subject medical device standards en_US
dc.subject medical device software verification and validation en_US
dc.subject V&V en_US
dc.title Improving verification & validation in the medical device domain 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.relation.projectid 07/SK/11299
dc.relation.projectid 08/IN.1/12030
dc.relation.projectid 03/CE2/I303_1

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