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

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dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Coleman, Gerry
dc.date.accessioned 2012-07-04T13:33:36Z
dc.date.available 2012-07-04T13:33:36Z
dc.date.issued 2007
dc.identifier.citation McCaffery, F et al (2007) "The need for a software process improvement model for the medical device industry," in International Review on Computers and Software (IRECOS) 2(1), pp. 10-15 en_US
dc.identifier.uri http://hdl.handle.net/10344/2320
dc.description peer-reviewed en_US
dc.description.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. en_US
dc.language.iso eng en_US
dc.publisher Praise Worthy Prize S.r.l. en_US
dc.relation.ispartofseries International Review on Computers and Software (IRECOS);2/1/pp 10-15
dc.rights 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. en_US
dc.subject medical sevice en_US
dc.subject software process improvement model en_US
dc.title The need for a software process improvement model for the medical device industry en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.contributor.sponsor SFI en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.authorcontactother fergal.mccaffery@dkit.ie
dc.internal.authorcontactother gerry.coleman@dkit.ie


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