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How amendments to the medical device directive affect the development of medical device software

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dc.contributor.author Mc Hugh, Martin
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Casey, Valentine
dc.date.accessioned 2011-12-15T15:25:45Z
dc.date.available 2011-12-15T15:25:45Z
dc.date.issued 2011
dc.identifier.uri http://hdl.handle.net/10344/1716
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. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare. en_US
dc.language.iso eng en_US
dc.relation.ispartofseries European Systems and Software Process Improvement and Innovation Conference EuroSP1 2011;
dc.subject IEC 62304 en_US
dc.subject medical device directive en_US
dc.subject MDD en_US
dc.subject software process improvement en_US
dc.title How amendments to the medical device directive affect the development of medical device software en_US
dc.type Conference item en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.type.restriction none en
dc.contributor.sponsor SFI
dc.contributor.sponsor Irish Software Engineering Research Centre
dc.relation.projectid 07/SK11299
dc.relation.projectid 08/IN1/12030
dc.relation.projectid 03/CE21303_1
dc.internal.authorcontactother fergal.mccaffery@dkit.ie
dc.internal.authorcontactother martin.mchugh@dkit.ie
dc.internal.authorcontactother val.casey@dkit.ie


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