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Standalone software as an active medical device

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dc.contributor.author Mc Hugh, Martin
dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Casey, Valentine
dc.date.accessioned 2011-12-15T15:57:10Z
dc.date.available 2011-12-15T15:57:10Z
dc.date.issued 2011
dc.identifier.uri http://hdl.handle.net/10344/1717
dc.description non-peer-reviewed en_US
dc.description.abstract With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way. en_US
dc.language.iso eng en_US
dc.publisher Springer-Verlag en_US
dc.relation.ispartofseries 11th International SPICE Conference;2011
dc.relation.uri http://dx.doi.org/10.1007/978-3-642-21233-8_9
dc.subject medical device en_US
dc.subject standards en_US
dc.subject IEC 62304 en_US
dc.subject MDD en_US
dc.subject software process improvement en_US
dc.title Standalone software as an active medical device 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 IGERDF
dc.relation.projectid 07/SK11299
dc.relation.projectid 08/IN.1/12030
dc.relation.projectid 03/CE2/1303_1
dc.internal.authorcontactother martin.mchugh@dkit.ie
dc.internal.authorcontactother val.casey@dkit.ie
dc.internal.authorcontactother Fergal.McCaffery@dkit.ie


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