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Verification & Validation in Medi SPICE

Sivakumar, M S and Casey, Valentine and Mc Caffery, Fergal and Coleman, Gerry (2011) Verification & Validation in Medi SPICE. In: 11th International SPICE Conference on Process Improvement and Capability Determination 2011, 30th May - 1st June 2011, Dublin City University, Ireland.

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Abstract

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple 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.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Medical device standards, Medical device software verification and validation, Medical device software process assessment and improvement
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Nicola Hanlon
Date Deposited: 10 Aug 2011 11:05
Last Modified: 11 Nov 2014 16:10
URI: http://eprints.dkit.ie/id/eprint/42

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