Standalone Software as an Active Medical Device

Authors

Martin McHugh, Technological University DublinFollow
Fergal McCaffery, Dundalk Institute of TechnologyFollow
Valentine Casey, Dundalk Institute of TechnologyFollow

Document Type

Conference Paper

Rights

Available under a Creative Commons Attribution Non-Commercial Share Alike 4.0 International Licence

Disciplines

Computer Sciences

Publication Details

The 11th International SPICE Conference Process Improvement and Capability dEtermination, Dublin, Ireland, 2011.

Abstract

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.

DOI

https://doi.org/10.1007/978-3-642-21233-8_9

Recommended Citation

Mc Hugh, M., McCaffrey, F., & Casey, V. (2011). Standalone Software as an Active Medical Device. The 11th International SPICE Conference Process Improvement and Capability Determination, Dublin, Ireland. doi:10.1007/978-3-642-21233-8_9

Funder

Science Foundation Ireland