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Development of a process assessment model for medical device software development

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dc.contributor.author Lepmets, Marion
dc.contributor.author Clarke, Paul
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Dorling, Alec
dc.date.accessioned 2015-03-27T18:33:15Z
dc.date.issued 2014
dc.identifier.uri http://hdl.handle.net/10344/4386
dc.description peer-reviewed en_US
dc.description.abstract Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by internation-al standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate re-sources addressing distinct areas of concern. The result for medical device software develop-ers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regula-tory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integration of regulatory standards from the medical device domain with generic software development process mod-els, resulting in a unified best practice framework for medical device software development. The process reference model for medical device software development is going to be pub-lished this year as IEC TR 80002-3, and the process assessment model for medical device software development is currently being validated through pilot studies in medical device in-dustry. This best practice framework will help small software developers in their adoption of regula-tions-compliant best practices while reducing the overhead associated with understanding the long list of regulations and standards they need to adhere to when developing software for medical devices. This framework will also help the manufacturers in selecting their software suppliers assuring that the suppliers have adopted the best practices and are compliant with the medical device standards and regulations. en_US
dc.language.iso eng en_US
dc.publisher Springer en_US
dc.relation.ispartofseries EuroSPI 2014 [Communications in Computer and Information Science];425
dc.rights The original publication is available at www.springerlink.com en_US
dc.subject process assessment model en_US
dc.subject process reference model en_US
dc.subject medical device software en_US
dc.subject medical device regulations en_US
dc.subject best practice framework en_US
dc.title Development of a process assessment model for medical device software development 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 EI en_US
dc.contributor.sponsor European Regional Development Fund en_US
dc.contributor.sponsor SFI en_US
dc.relation.projectid CF/2012/2631 en_US
dc.relation.projectid 07/SK/I1299 en_US
dc.date.embargoEndDate 2015-06-27
dc.embargo.terms 2015-06-27 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


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