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ZenoXCareRegulated Digital Health

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Pan-African standards & compliance — full registry, 54-country index.

SOC 2 Type IIIn progress
AfCFTA Digital Trade ProtocolAligned
AU Data Policy FrameworkAligned
ECOWAS Data Protection ActAligned
HL7 FHIR R5Aligned
ICD-11Aligned
ISO 22301:2019Aligned
ISO 27799:2016Aligned

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Medical Device (Reserved)

Standards category·2 standards

Medical Device (Reserved)

Standards held in reserve until any feature is classified as Software as a Medical Device.

Monitoring
ISO 13485:2016
ISO
Quality management systems for medical devices — requirements for regulatory purposes.
Monitoring
IMDRF SaMD Framework
International Medical Device Regulators Forum
Regulatory framework for Software as a Medical Device — risk categorisation and clinical evaluation guidance.

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