Standalone software as an active medical device

Martin McHugh, Fergal McCaffery, Valentine Casey

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

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.

Original languageEnglish
Title of host publicationSoftware Process Improvement and Capability Determination - 11th International Conference, SPICE 2011, Proceedings
PublisherSpringer Verlag
Pages97-107
Number of pages11
ISBN (Print)9783642212321
DOIs
Publication statusPublished - 2011
Externally publishedYes

Publication series

NameCommunications in Computer and Information Science
Volume155 CCIS
ISSN (Print)1865-0929

Keywords

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

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