Under Review
v1.0.4-LATEST
Software as a Medical Device
Architectural Definition
Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
Schema Preview
● application/json
{
"entity": "software-as-a-medical-device",
"domain": "pharmacy",
"metadata": {
"displayName": "Software as a Medical Device",
"status": "DRAFT",
"version": "1.0.4",
"isStandardized": false
}
}Standard
ISO-8601
Data Type
String/Obj
Steward
Arch Council
Verified
Feb 2026