Operational AI Governance™
SmartRisk helps regulated organizations identify AI, evaluate risk, direct remediation, validate controls, and maintain defensible evidence across the AI lifecycle.
Built for decisions where trust must be demonstrated
Medical DevicesPharma & BiotechHealth SystemsDigital HealthTwo products. One governance journey.
SmartRisk 1 accelerates structured risk analysis. SmartRisk 2 provides the operating layer for enterprise AI governance, evidence, and assurance.
Guided FMEA workflows that reduce manual effort, improve consistency, and produce decision-ready risk documentation.
An executive governance instrument connecting AI inventory, risk, validation, remediation, evidence, and continuous monitoring.
From inventory to assurance
Every capability supports a decision, an accountable owner, and evidence that can withstand executive, customer, and regulatory scrutiny.
Know every AI system, owner, intended use, status, and dependency.
Classify risk consistently and surface the decisions that require human judgment.
Connect controls to traceable evidence instead of scattered documents and claims.
See whether governance remains effective as systems, evidence, and obligations change.
Purpose-built for regulated environments
Govern AI across product, quality, regulatory, and post-market workflows.
Bring evidence, validation, and accountability into AI-enabled GxP decisions.
Create clear ownership and oversight for clinical and operational AI.
Turn governance into buyer confidence and implementation readiness.
Consulting + platform
Engage SmartRisk for readiness assessments, medical AI governance, framework development, validation, remediation, implementation, executive workshops, or fractional governance leadership.
View consulting servicesInteractive decision tools
Assess governance readiness or estimate the labor-capacity value of a more structured SmartRisk 1 workflow.
Receive a directional maturity score, identify the lowest-scoring dimensions, and download a concise result.
Take the assessmentEstimate baseline effort, annual hours redirected, and labor-capacity value using your own assumptions.
Calculate SR1 valueThe forthcoming field guide
A practical guide for leaders navigating AI risk, accountability, validation, regulatory expectations, evidence, and continuous assurance across the medical AI lifecycle.
Preview the bookBegin with an executive conversation, a readiness assessment, or a focused SmartRisk pilot.
Request a conversation