Search results with tag "Software as a medical device"
'Software as a Medical Device': Possible Framework for ...
www.imdrf.org3.1 Software as a Medical Device . The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. NOTES: • SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device. •
Proposed document: Software as a Medical Device …
imdrf.org1 2 IMDRF/SaMD WG (PD1)/N23R3 3 4 5 6 7 8 9 10 11 12 13 PROPOSED DOCUMENT 14 International Medical Device Regulators Forum 15 16 17 18 Title: Software as a Medical Device (SaMD): Application of Quality
Software as a Medical Device (SaMD): Key definitions
www.imdrf.orgThe term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes perform these that purposes without being part of a hardware medical device. NOTES: • SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.