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Improving Verification & Validation in the Medical Device Domain

Sivakumar, M S and Casey, Valentine and Mc Caffery, Fergal and Coleman, Gerry (2011) Improving Verification & Validation in the Medical Device Domain. In: European Systems and Software Process Improvement and Innovation Conference, EuroSPI 2011, 27th - 29th June 2011, Roskilde University, Denmark.

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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.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Medical device standards; Medical device software verification and validation; V&V; Medical device software process assessment and improvement; Medi SPICE
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Nicola Hanlon
Date Deposited: 16 Aug 2011 08:37
Last Modified: 11 Nov 2014 16:10
URI: http://eprints.dkit.ie/id/eprint/53

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