Answers for teams evaluating what comes next.

SmartRisk is designed for organizations that need a clearer, more defensible way to manage product risk or enterprise AI governance. Typical stakeholders include product and engineering teams, quality and regulatory leaders, AI governance owners, risk and compliance functions, legal teams, and executives accountable for technology oversight.

SmartRisk 1 focuses on structured product risk analysis and FMEA workflows, helping teams collaborate, improve documentation consistency, and produce audit-ready outputs. SmartRisk 2 is the evolving enterprise AI governance layer, designed around inventory, profiling, risk evaluation, validation, remediation, evidence, and monitoring. Organizations can use either product independently or connect them as part of a broader operating model.

SmartRisk is shaped by medical-device quality and risk practices. It can support alignment across design controls, ISO 14971 risk management, quality systems, validation, traceability, change control, post-market signals, and regulatory evidence. It does not certify compliance or replace your quality management system, regulatory experts, or professional judgment.

SmartRisk is designed to preserve the context behind a decision: the system or risk considered, the people involved, the rationale, the selected controls, approvals, validation records, changes, and follow-up actions. This can make internal review and audit preparation more consistent. The exact evidence required remains specific to your organization, product, market, and applicable procedures.

Deployment and integration scope are planned around the customer’s operating model, systems, and security requirements. During discovery, the SmartRisk team can map current workflows, sources of record, identity needs, evidence repositories, and handoffs. Available connectors, hosting options, data migration, and implementation timelines should be confirmed for your specific engagement.

Security and responsible data handling are treated as core governance concerns. A product conversation should cover access control, roles, data boundaries, retention, hosting, encryption, incident processes, and any regulated or sensitive information in scope. SmartRisk does not publish unverified certification claims here; current security documentation and contractual commitments are provided during diligence.