risk-management-specialist

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.