SmartRisk 1
Guided FMEA workflows that reduce manual effort, improve consistency, and produce decision-ready risk documentation.
- Structured FMEA workflow
- Reusable risk logic
- Clear document outputs
- Faster cross-functional review
Operational AI Governance™
Move AI governance
from policy to proof.
SmartRisk helps regulated organizations identify AI, evaluate risk, direct remediation, validate controls, and maintain defensible evidence across the AI lifecycle.
✓ Regulated-industry focus✓ Evidence-based governance
Built for decisions where trust must be demonstratedMedical DevicesPharma & BiotechHealth SystemsDigital Health
Two products. One governance journey.
Start focused. Scale with confidence.
SmartRisk 1 accelerates structured risk analysis. SmartRisk 2 provides the operating layer for enterprise AI governance, evidence, and assurance.
SmartRisk 2
An executive governance instrument connecting AI inventory, risk, validation, remediation, evidence, and continuous monitoring.
- Enterprise AI Registry™
- Risk and classification engine
- Governance remediation
- Evidence-backed assurance
From inventory to assurance
A continuous governance system. Not another static checklist.
Every capability supports a decision, an accountable owner, and evidence that can withstand executive, customer, and regulatory scrutiny.
AI Registry™
Know every AI system, accountable owner, intended use, status, and dependency.
Risk Engine™
Classify risk consistently and surface the decisions that require human judgment.
Evidence Vault™
Connect controls to traceable evidence instead of scattered documents and claims.
Continuous Monitoring™
See whether governance remains effective as systems, evidence, and obligations change.
Purpose-built for regulated environments
Governance that understands the consequence of the decision.
Medical devices
Govern AI across product, quality, regulatory, and post-market workflows.
Pharma & biotech
Bring evidence, validation, and accountability into AI-enabled GxP decisions.
Health systems
Create clear ownership and oversight for clinical and operational AI.
Digital health & AI vendors
Turn governance into buyer confidence and implementation readiness.
Consulting + platform
Assess what exists. Build what is missing. Operate what matters.
Readiness assessments, framework development, validation, remediation, executive workshops, and fractional governance leadership.
View consulting services →The operating discipline
01 Assess
Inventory, maturity, governance gaps.
02 Implement
Controls, validation, accountable remediation.
03 Assure
Evidence, monitoring, and executive oversight.
Interactive decision tools
Turn interest into a practical next step.
AI governance readiness assessment
Receive a directional maturity score, identify focus areas, and download your results.
Take the assessment →FMEA value calculator
Estimate baseline effort, annual hours redirected, and labor-capacity value using your own assumptions.
Calculate SR1 value →SmartRisk Field GuideMedical AI
GovernanceFrom principles to operational proof
GovernanceFrom principles to operational proof
Forthcoming professional field guide
Medical AI governance, made operational.
A practical paid publication for leaders navigating AI risk, accountability, validation, evidence, and continuous assurance. Selected previews and LinkedIn perspectives live in Insights.
Make AI governance defensible before it becomes urgent.
Begin with a focused conversation, a readiness assessment, or a SmartRisk pilot.