McCaffery, 2007.pdf (500.03 kB)
The need for a software process improvement model for the medical device industry
journal contribution
posted on 2012-07-04, 13:33 authored by Fergal Mc Caffery, Gerry ColemanSoftware 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.
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International Review on Computers and Software (IRECOS);2/1/pp 10-15Publisher
Praise Worthy Prize S.r.l.Note
peer-reviewedOther Funding information
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Copyright © 2007, Praise Worthy Prize S.r.l.. with permission of Praise Worthy Prize S.r.l.. from the International Review on Computers and Software, IRECOS, Vol. 2 n°1.Language
EnglishUsage metrics
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