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Real-World Health for Clinical AI
The compliance intelligence layer for medical device and clinical AI teams
Compliance intelligence for clinical AI.
Close Compliance Gaps Before They Become Findings
AI governance across the lifecycle
Clarity on Clinical AI safety and efficacy from production to deployments, measured by the compliance metrics FDA and hospitals resonate with
Clinical AI production
Hospital deployment
Patient-level endpoints
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Build and Audit
IEC 62304 design controls, with AI Auditor mapping each finding to a clause.
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Monitor
Clinical AI Monitoring watches the deployed model and drafts the surveillance file.
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Engage patients
The Stroke Patient App records stroke-related risk factors and activities. Investigational device. Not cleared or approved by FDA.
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