University of Limerick Institutional Repository

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

DSpace Repository

Show simple item record

dc.contributor.author Mc Hugh, Martin
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Casey, Valentine
dc.date.accessioned 2012-11-14T15:18:04Z
dc.date.available 2012-11-14T15:18:04Z
dc.date.issued 2012
dc.identifier.uri http://hdl.handle.net/10344/2671
dc.description peer-reviewed en_US
dc.description.abstract A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be developed following state of the art medical device software development processes. State of the art medical device software processes is understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This paper identifies how changes to the MDD affect medical device software development companies and recommendations are made as to how medical device software development companies can conform to the latest regulatory requirements. Additionally, the paper provides an overview of how Medi SPICE is currently being developed to provide organisations with a single point of reference for the practices that should be implemented in order to produce regulatory compliant medical device software. en_US
dc.language.iso eng en_US
dc.publisher The Institution of Engineering and Technology en_US
dc.relation.ispartofseries IET Software;6(5), pp. 431-457
dc.relation.uri http://dx.doi.org/10.1049/iet-sen.2011.0198
dc.rights © The Institution of Engineering and Technology en_US
dc.subject IEC 62304 en_US
dc.subject medical device directive en_US
dc.subject software process improvement en_US
dc.title Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive 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.relation.projectid 07/SK/I1299 en_US
dc.relation.projectid 08/IN.I/I2030 en_US
dc.relation.projectid 03/CE2/I303_1 en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.authorcontactother fergal.mccaffery@dkit.ie
dc.internal.authorcontactother martin.mchugh@dkit.ie
dc.internal.authorcontactother val.casey@dkit.ie


Files in this item

This item appears in the following Collection(s)

Show simple item record

Search DSpace


Browse

My Account

Statistics