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Verification & validation in medi spice

Date
2011
Abstract
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
Supervisor
Description
non-peer-reviewed
Publisher
Citation
11th International SPICE Conference on Process Improvement and Capability dEtermination;05/2011
Collections
Lero - The Science Foundation Ireland Research Centre for Software
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2011_Sivakumar.pdf
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Keywords
medical device standards, medical devices software verification and validation, medical device software process assessment and improvement
ULRR Identifiers
https://hdl.handle.net/10344/1708
 https://doi.org/10.34961/9625
Funding code
Funding Information
Science Foundation Ireland (SFI)
Sustainable Development Goals
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