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Medi SPICE and the development of a process reference model for inclusion in IEC 62304

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dc.contributor.author Casey, Valentine
dc.contributor.author Mc Caffery, Fergal
dc.date.accessioned 2012-12-06T16:08:06Z
dc.date.available 2012-12-06T16:08:06Z
dc.date.issued 2012
dc.identifier.uri http://hdl.handle.net/10344/2738
dc.description peer-reviewed en_US
dc.description.abstract The demand for medical device software continues to grow and there is an associated increase in its importance and complexity. This paper discusses medical device software process assessment and improvement. It outlines Medi SPICE, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software - Software life cycle processes. IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union. This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE. Finally the timeline for the release of the full Medi SPICE model is provided. en_US
dc.language.iso eng en_US
dc.relation.ispartofseries ICSOFT 2012 the 7th International Conference on Software Paradigm Trends;
dc.subject medical device software en_US
dc.subject software development en_US
dc.subject software process assessment en_US
dc.subject software process improvement en_US
dc.subject Medi Spice en_US
dc.subject IEC 62304 en_US
dc.title Medi SPICE and the development of a process reference model for inclusion in IEC 62304 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
dc.relation.projectid 07/SK/I1299 en_US
dc.relation.projectid 08/IN.1/I2030 en_US
dc.relation.projectid 10/CE/I1855 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.authorcontactother val.casey@dkit.ie
dc.internal.authorcontactother fergal.mccaffery@dkit.ie


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