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

Mc Hugh, Martin and McCaffery, Fergal and Casey, Valentine (2011) How amendments to the medical device directive affects the development of medical device software. In: Systems, Software and Services Process Improvement, June 29th & 30th 2011, Roskilde, Denmark.

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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 de-velopment 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.

Item Type:	Conference or Workshop Item (Paper)
Uncontrolled Keywords:	IEC 62304; Medical Device Directive; MDD; Software Process Improvement; 2007/47/EC; AIMD; Medi SPICE
Subjects:	Computer Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Martin McHugh
Date Deposited:	04 Jul 2011 10:57
Last Modified:	11 Nov 2014 16:09
URI:	https://eprints.dkit.ie/id/eprint/39

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