ISO 14971 Compliant

Clinical Safety,
Simplified.

The next-generation Hazard Log for modern medical software. Seamlessly integrated with Jira for deep bi-directional traceability.

Deep Jira Synchronization

Real-time validation of ticket IDs. Ensure every mitigation is linked to a live backlog item, automatically tracking status changes.

Compliance First

Built for ISO 14971 and DCB0129. Manage Hazards, Causes, and Mitigations with a strict schema and audit-ready reporting.

Smart Risk Matrix

Automated 5x5 risk calculation (Severity x Likelihood). Visual feedback instantly updates as you adjust pre- and post-mitigation scores.