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MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE

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dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Richardson, Ita
dc.date.accessioned 2012-05-15T10:43:57Z
dc.date.available 2012-05-15T10:43:57Z
dc.date.issued 2007
dc.identifier.citation International SPICE Days 2007 en_US
dc.identifier.uri http://hdl.handle.net/10344/2177
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 extending relevant practices from Automotive SPICE. en_US
dc.language.iso eng en_US
dc.rights info:eu-repo/semantics/openAccess en_US
dc.subject medical devices en_US
dc.subject software process improvement en_US
dc.subject FDA en_US
dc.title MedeSPI: a software process improvement model for the medical device industry based upon Automotive SPICE en_US
dc.type info:eu-repo/semantics/conferenceObject en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.contributor.sponsor SFI en_US

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