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Improving verification & validation in the medical device domain
Sivakumar, M.S.; Casey, Valentine; Mc Caffery, Fergal; Coleman, Gerry
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
Keyword(s): medical device standards; medical device software verification and validation; V&V
Publication Date:
Type: Conference item
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): European Systems and Software Process Improvement and Innovation Conference (Euro SPI);06/2011
Publisher(s): Springer
First Indexed: 2012-01-08 05:27:41 Last Updated: 2015-12-18 05:28:05