Safety Risk for Jira

Manage medical device and IVD risk directly in Jira with structured Risk Sheets, configurable risk models and complete traceability from hazard to control to verification. Link each risk directly to the design, process or safety controls that mitigate it and to the tests that verify control effectiveness. Automatically maintain a Risk Traceability Matrix that gives teams and auditors a clear, current view of risk evaluation, mitigation, verification and residual risk.