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Software Process Improvement To Assist Medical Device Software Development Organisations To Comply With The Amendments To The Medical Device Directive, Martin Mchugh, Fergal Mccaffery, Valentine Casey
Software Process Improvement To Assist Medical Device Software Development Organisations To Comply With The Amendments To The Medical Device Directive, Martin Mchugh, Fergal Mccaffery, Valentine Casey
Articles
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 …