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Standalone software as an active medical device
Mc Hugh, Martin; Mc Caffery, Fergal; Casey, Valentine
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.
Keyword(s): medical device; standards; IEC 62304; MDD; software process improvement
Publication Date:
Type: Conference item
Peer-Reviewed: No
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): 11th International SPICE Conference;2011
Publisher(s): Springer-Verlag
First Indexed: 2011-12-23 05:27:48 Last Updated: 2019-09-19 06:28:26