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Improving verification & validation in the medical device domain
Date
2011
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
Supervisor
Description
peer-reviewed
Publisher
Springer
Citation
European Systems and Software Process Improvement and Innovation Conference (Euro SPI);06/2011
Files
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2011_Sivakumar.pdf
Adobe PDF, 116.76 KB
ULRR Identifiers
Funding code
Funding Information
Science Foundation Ireland (SFI)