SmartRisk unites product-level risk analysis with enterprise AI governance—so regulated organizations can discover risk, authorize action, validate controls, and maintain defensible evidence.
✓Intended use definedApproved by Product Owner
✓Product risks linkedSmartRisk 1 record connected
!Validation evidence pendingHuman approval blocked until complete
ISO 14971
risk management
Design controls
& validation
Human oversight
& accountability
Audit-ready
evidence
Two products. One risk system.
SmartRisk is designed around a simple idea: governance becomes credible when high-level decisions remain connected to the underlying risks, controls, validation, and evidence.
SmartRisk 1
Modernize FMEA and risk-analysis work with a consistent, collaborative workflow that improves traceability and documentation quality.
SmartRisk 2
Build a living governance record for every AI system—connecting context, risk, approval, validation, evidence, remediation, and monitoring.
The operational governance loop
Every decision creates evidence. Every change can trigger reassessment. Every material risk stays visible to the people accountable for it.
Register the system, its purpose, owners, users, data, and operating context.
Evaluate product, patient, operational, compliance, and organizational risk.
Route consequential decisions to accountable human reviewers.
Assign safeguards, evidence requirements, remediation, and due dates.
Demonstrate that requirements and controls perform as intended.
Watch change, performance, incidents, and residual risk over time.
SmartRisk 2 capability system
These modules describe the intended SR2 platform architecture. Availability will expand as development and validation progress.
A governed inventory of AI systems, models, applications, vendors, owners, and status.
Structured context for intended use, affected people, data, decisions, and impact.
Consistent, contextual evaluation across enterprise, product, and regulated-use risks.
Requirements, test strategy, results, exceptions, and approval connected in one record.
Convert governance gaps into owned corrective work with due dates and evidence.
Preserve artifacts, rationale, approvals, and traceability for inspection and audit.
Use operational signals and changes to trigger reassessment and intervention.
SmartRisk 1 provides the current product-risk foundation. SmartRisk 2 is in active development. Product conversations will distinguish available, pilot, and planned functionality.
Purpose-built specialization
Begin with medical-device rigor. Extend through life sciences and healthcare with specialized governance packs built on the same core platform.
Connect AI oversight with ISO 14971 risk management, design controls, validation, change control, and postmarket evidence.
Discuss this use case →Govern AI context of use, GxP impact, model credibility, clinical development, manufacturing, and lifecycle evidence.
Discuss this use case →Control AI used for study design, recruitment, endpoints, digital technologies, vendors, and regulatory evidence.
Discuss this use case →Support accountable use of clinical, administrative, and generative AI across hospitals and medical groups.
Discuss this use case →The SmartRisk difference
General AI governance platforms organize enterprise oversight. SmartRisk is being designed to connect that oversight to the product risk, quality-system, validation, and lifecycle evidence behind regulated decisions.
Why SmartRisk →Link enterprise AI decisions to hazards, failure modes, controls, and residual risk.
Preserve who decided, what evidence they reviewed, and why authorization was granted.
Bring validation, change control, postmarket signals, and remediation into governance.
Build defensible AI governance
See how SmartRisk 1 and SmartRisk 2 can connect product risk, human accountability, validation, and evidence.