ISO/IEC 42001 vendors for Healthcare

Vendors that support ISO/IEC 42001:2023 AI Management System and explicitly serve healthcare customers. Listings verified April 21, 2026.

VendorHQFoundedSizePricingLast verified
CalypsoAISan Mateo, United States201851-200Enterprise only.Apr 21, 2026
Prompt SecurityTel Aviv, Israel202311-50Now part of SentinelOne Singularity Platform. Continues as a standalone product. Enterprise pricing only; contact sales or SentinelOne.Apr 22, 2026
Holistic AILondon, United Kingdom202051-200Enterprise-only with modular pricing by use case.Apr 21, 2026
EnzaiBelfast, United Kingdom20212-10SaaS platform, enterprise subscription. No public pricing listed. Contact sales via enz.ai.Apr 22, 2026
Fairly AIKitchener, Canada202011-50On-premises or private-cloud deployments; quote-based.Apr 21, 2026
Credo AISan Francisco, United States202051-200Enterprise-only; typical engagements start in the mid-five figures annually.Apr 21, 2026
Collibra AI GovernanceNew York, United States20081000+Enterprise subscription; contact sales for custom quote based on users, assets, modules.Apr 23, 2026
Fiddler AIPalo Alto, United States201851-200Contact for pricingApr 21, 2026
OneTrust AI GovernanceAtlanta, United States20161000+Enterprise platform; contact sales for quote, no public pricing listedApr 23, 2026
TrustibleArlington, United States202311-50Contact sales for enterprise pricing; no public plans listedApr 23, 2026
ModelOpChicago, United States201811-50No public pricing listed; contact sales for enterprise quotes.Apr 23, 2026

About ISO/IEC 42001

ISO/IEC 42001 is the first international certifiable management system standard specifically for AI. It specifies requirements for establishing, implementing, maintaining, and continually improving an AI management system (AIMS). Increasingly treated by procurement teams as the SOC 2 equivalent for AI — a signal that an organization has mature, auditable AI governance.

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About Healthcare

Hospitals, payers, and digital health companies using AI for clinical decision support, imaging, coding, prior authorization, and patient engagement. Regulated by FDA SaMD, HIPAA, and HHS Section 1557 non-discrimination rules in addition to AI-specific laws.

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