Medical devices
Align AI use, software risk, quality, clinical context, change, and post-market evidence.
Solutions
AI governance designed around the environment and the decision.
SmartRisk combines a regulated-industry perspective with a repeatable governance system. Begin with your sector—or with the governance problem that needs to be solved.
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Where AI meets real-world consequence.
Each solution translates common governance principles into the roles, evidence, workflows, and decisions that matter in its operating context.
Pharmaceutical & biotech
Support proportionate governance and evidence for AI-enabled discovery, quality, clinical, and operational processes.
Hospitals & health systems
Create visibility, ownership, validation, and oversight across clinical and administrative AI.
Medical groups
Govern AI-enabled documentation, decision support, operations, and patient-facing workflows.
Digital health
Demonstrate controlled design, intended use, evidence, change management, and ongoing performance.
AI vendors & consultants
Package governance evidence that supports procurement, implementation, and customer trust.
By governance need
Enter wherever the evidence breaks down.
You do not need to solve every governance problem at once. Start with the highest-friction decision and build a stronger operating system from there.
Inventory & classification
Find AI systems, establish ownership, capture intended use, and determine the governance pathway.
Risk & validation
Evaluate harm, impact, reliability, data, users, and use context—then define evidence proportionate to risk.
Remediation
Turn governance gaps into prioritized actions with accountable owners, due dates, and acceptance evidence.
Evidence & monitoring
Maintain control-to-evidence traceability and watch the signals that indicate governance drift.