ZenoXCare — marketing
Loading standard details…
ISO 13485:2016
Quality management systems for medical devices — requirements for regulatory purposes.
MonitoringAuthoritative source ↗
ZenoXCare scope under ISO 13485:2016
Reserved for the eventuality that ZenoXCare ships a feature classified as Software as a Medical Device (SaMD).
Frequently asked
- What is ISO 13485:2016?
- ISO 13485:2016 is published by ISO. Quality management systems for medical devices — requirements for regulatory purposes.
- Is ZenoXCare aligned to ISO 13485:2016?
- Yes — ZenoXCare's alignment to ISO 13485:2016 is monitored — tracked for awareness; no formal alignment claim is published. Scope: Reserved for the eventuality that ZenoXCare ships a feature classified as Software as a Medical Device (SaMD).
- Where can I read the authoritative source for ISO 13485:2016?
- ISO 13485:2016 is published at https://www.iso.org/standard/59752.html by ISO. 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 ISO 13485:2016?
- For ISO 13485:2016 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.