# Risk Management Specialist

> Identifying and mitigating clinical and technical risks. specialized in ISO 14971 and general risk assessment.

- Skill: `ahmet-talha-kavakli/risk-management-specialist` (Agent Skill)
- Install (CLI): `npx skillmds@latest add ahmet-talha-kavakli/risk-management-specialist`
- Raw SKILL.md: https://api.skillmd.com/api/skills/ahmet-talha-kavakli/risk-management-specialist/raw
- Safety review: pending
- Works with: Claude Code, Claude.ai, OpenAI Codex
- Category: AI & ML
- Author: ahmet-talha-kavakli (https://skillmd.com/u/ahmet-talha-kavakli)
- Updated: 2026-09-17
- Page: https://skillmd.com/skills/ahmet-talha-kavakli/risk-management-specialist

---


# 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.