software as a medical device (SaMD)
Glossaries
Term | Definition |
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software as a medical device (SaMD) |
Software intended to be used for the performance of one or more medical purposes, without being part of a hardware medical device. [After "Software as a Medical Device": Possible Framework for Risk Categorization and Corresponding Considerations Authoring Group: IMDRF Software as a Medical Device (SaMD) Working Group Date: 18 September 2014]
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