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Verification & validation in medi spice
Sivakumar, M.S.; Casey, Valentine; Mc Caffery, Fergal; Coleman, Gerry
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
Keyword(s): medical device standards; medical devices software verification and validation; medical device software process assessment and improvement
Publication Date:
2011
Type: Conference item
Peer-Reviewed: No
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): 11th International SPICE Conference on Process Improvement and Capability dEtermination;05/2011
07/SK/I1299
08/IN.1/I2030
First Indexed: 2011-12-16 05:27:44 Last Updated: 2015-12-18 05:28:00