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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.
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