Now accepting beta applications
AI Governance Built for
Regulated Industries.
FulcrumIQ gives compliance, quality, and AI teams a structured workspace to validate AI systems against FDA SaMD, NIST AI RMF, and HIPAA — with full audit trails and evidence capture built in.
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Structured IQ / OQ / PQ workflows
Pre-built validation stages mapped to FDA SaMD, NIST AI RMF, HIPAA, and ISO 42001.
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Test execution & evidence capture
Run test cases, log results, and auto-generate audit-ready evidence packages.
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Findings management & sign-off
Track defects through resolution with a full audit trail and digital sign-off.
Supported Frameworks
FDA SaMDNIST AI RMFHIPAAISO 42001Colorado AI Act
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