Thumbnail Image
Publication

Standalone software as an active medical device

Date
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.
Supervisor
Description
non-peer-reviewed
Publisher
Springer-Verlang
Citation
11th International SPICE Conference;2011
Collections
Lero - The Science Foundation Ireland Research Centre for Software
Show all metadata
Files
Thumbnail Image
2011_McHugh%20%282%29.pdf
Adobe PDF, 376.39 KB
Keywords
medical device, standards, IEC 62304, MDD, software process improvement
ULRR Identifiers
https://researchrepository.ul.ie/handle/10344/1717
 https://doi.org/10.34961/756
Funding code
Funding Information
Science Foundation Ireland (SFI), IGEuropean Regional Development Fund (ERDF)
Sustainable Development Goals
External Link
Type
Meetings and Proceedings
Rights
https://creativecommons.org/licenses/by-nc-sa/1.0/
License