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Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive
Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine
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.
Keyword(s): IEC 62304; medical device directive; software process improvement
Publication Date:
2012
Type: Journal article
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): IET Software;6(5), pp. 431-457
http://dx.doi.org/10.1049/iet-sen.2011.0198
07/SK/I1299
08/IN.I/I2030
03/CE2/I303_1
Publisher(s): The Institution of Engineering and Technology
First Indexed: 2014-09-25 05:37:16 Last Updated: 2019-09-19 06:27:37