Standalone Software as an Active Medical Device

  • Martin McHugh
  • Fergal McCaffery
  • Valentine Casey
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 155)


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.


Medical Device Standards IEC 62304 MDD (2007/47/EC) Software Process Improvement 


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Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • Martin McHugh
    • 1
  • Fergal McCaffery
    • 1
  • Valentine Casey
    • 1
  1. 1.Regulated Software Research GroupDundalk Institute of Technology & LeroDundalkIreland

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