The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
Software as a Medical Device (SaMD): Key Definitions
This document IMDRF SaMD WG N10/Software as a Medical Device: Key Definitions focuses on a common definition for when software is considered to be a medical device and a reminder of other key terms, some previously defined in Global Harmonization Task Force (GHTF) documents, with relevance to SaMD.