Standalone Software as an Active Medical Device

Mc Hugh, Martin and McCaffery, Fergal and Casey, Valentine (2011) Standalone Software as an Active Medical Device. In: Software Process Improvement and Capability Determination SPICE 2011, May 30th, June 1st , Dublin, ireland.

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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.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Medical Device Standards; IEC 62304; MDD (2007/47/EC); Software Process Improvement
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 16:10

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