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Medical device (reserved)·International Medical Device Regulators Forum
IMDRF SaMD Framework
Regulatory framework for Software as a Medical Device — risk categorisation and clinical evaluation guidance.
MonitoringAuthoritative source ↗
ZenoXCare scope under IMDRF SaMD Framework
Reserved; assessment trigger is any AI/CDS feature making regulated medical claims.
Frequently asked
- What is IMDRF SaMD Framework?
- IMDRF SaMD Framework is published by International Medical Device Regulators Forum. Regulatory framework for Software as a Medical Device — risk categorisation and clinical evaluation guidance.
- Is ZenoXCare aligned to IMDRF SaMD Framework?
- Yes — ZenoXCare's alignment to IMDRF SaMD Framework is monitored — tracked for awareness; no formal alignment claim is published. Scope: Reserved; assessment trigger is any AI/CDS feature making regulated medical claims.
- Where can I read the authoritative source for IMDRF SaMD Framework?
- IMDRF SaMD Framework is published at https://www.imdrf.org/working-groups/software-medical-device-samd by International Medical Device Regulators Forum. ZenoXCare links to this canonical source on the standard's entity page so customers and regulators verify against the publisher directly.
- Is there a third-party certification for IMDRF SaMD Framework?
- For IMDRF SaMD Framework ZenoXCare publishes alignment status only — no third-party attestation is currently on the roadmap. The alignment claim is enforced by the build-time guard verify:standards-registry.
Every standard on this page is anchored to its publisher's authoritative source — linked above. ZenoXCare's alignment status is reviewed quarterly by our compliance team and verified independently by the auditors who issue our certifications. To request the underlying evidence pack, please contact compliance.