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Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304

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dc.contributor.author Rust, Peter
dc.contributor.author Flood, Derek
dc.contributor.author Mc Caffery, Fergal
dc.date.accessioned 2017-02-07T14:10:19Z
dc.date.available 2017-02-07T14:10:19Z
dc.date.issued 2016
dc.identifier.uri http://hdl.handle.net/10344/5503
dc.description peer-reviewed en_US
dc.description.abstract One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in or-der to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical device software development domain, by the use of design patterns to generate “How-to” artefacts, overcome the challenge of demonstrating compliance en_US
dc.language.iso eng en_US
dc.publisher Springer en_US
dc.relation.ispartofseries 16th International Conference, SPICE 2016: Communications in Computer and Information Science;609, pp. 43-56
dc.relation.uri http://dx.doi.org/10.1007/978-3-319-38980-6_4
dc.rights The original publication is available at www.springerlink.com en_US
dc.subject SME’s en_US
dc.subject medical device software en_US
dc.subject medical device standards en_US
dc.subject regulatory compliance en_US
dc.subject software roadmap en_US
dc.subject software process improvement en_US
dc.subject software process improvement roadmaps en_US
dc.subject IEC 62304 en_US
dc.subject design patterns en_US
dc.title Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of 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.identifier.doi 10.1007/978-3-319-38980-6_4
dc.contributor.sponsor SFI en_US
dc.relation.projectid 08/IN.1/I2030 en_US
dc.relation.projectid 10/CE/I1855 en_US
dc.relation.projectid 13/RC/20194 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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