▸ // HEALTHTECH × ISO 42001
ISO 42001 for Indian healthtech
AI-driven diagnosis assist, radiology triage and prescription checks are ISO 42001-scope activities. Combined with CDSCO SaMD, they define the current AI-medical-device audit stack in India.
What's at stake
- ·Diagnostic AI needs both CDSCO SaMD + ISO 42001 governance
- ·US market entry additionally needs HIPAA + FDA SaMD alignment
- ·Bias-and-drift monitoring is an ISO 42001 control area
Bharat NeuroTech offer
- ·Dr. Sodhi ANSI/ABICB ISO 42001 lead auditor — ₹24,499
- ·Stack with CDSCO SaMD guided audit at ₹1,799
- ·Bias-and-drift monitoring template mapped to ISO 42001 controls