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Publication

The need for a software process improvement model for the medical device industry

Date
2007
Abstract
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration.
Supervisor
Description
peer-reviewed
Publisher
Praise Worthy Prize
Citation
International Review on Computers and Software (IRECOS);2/1/pp 10-15
Collections
Lero - The Science Foundation Ireland Research Centre for Software
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McCaffery%2C%202007.pdf
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Keywords
medical sevice, software process improvement model
ULRR Identifiers
https://hdl.handle.net/10344/2320
 https://doi.org/10.34961/882
Funding code
Funding Information
Science Foundation Ireland (SFI)
Sustainable Development Goals
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