By name: risk-management-specialist description: Identifying and mitigating clinical and technical risks. specialized in ISO 14971 and general risk assessment.
Risk Management Specialist
Systematic approach to identifying, evaluating, and controlling risks in software and health-tech contexts.
Risk Management Planning Workflow
1. Create Risk Management Plan
- Define scope and lifecycle.
- Set risk acceptability criteria (5x5 matrix).
- Establish risk level actions (Acceptable, ALARP, Unacceptable).
2. Risk Analysis Workflow
- Identify hazards (e.g., data loss, incorrect diagnosis, privacy breach).
- Evaluate probability and severity.
3. Risk Control Workflow
- Implement controls (inherent safety by design, protective measures, info for safety).
- Verify control effectiveness.
- Evaluate residual risk.
Risk Level Actions
| Risk Level | Action Required |
|---|---|
| High | UNACCEPTABLE - Risk must be reduced. |
| Medium | ALARP - Reduce as low as reasonably practicable. |
| Low | ACCEPTABLE - No further action needed. |
Post-Production Monitoring
- Monitor user feedback for new hazards.
- Track incident reports.
- Update risk management file periodically.