risk-management-specialist

The saved excerpt is a snapshot from when this skill was listed. The external source remains the complete and most current version.

---
name: "risk-management-specialist"
description: Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
---

# Risk Management Specialist

ISO 14971:2019 risk management implementation throughout the medical device lifecycle.

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## Table of Contents

- [Risk Management Planning Workflow](#risk-management-planning-workflow)
- [Risk Analysis Workflow](#risk-analysis-workflow)
- [Risk Evaluation Workflow](#risk-evaluation-workflow)
- [Risk Control Workflow](#risk-control-workflow)
- [Post-Production Risk Management](#post-production-risk-management)
- [Risk Assessment Templates](#risk-assessment-templates)
- [Decision Frameworks](#decision-frameworks)
- [Tools and References](#tools-and-references)

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## Risk Management Planning Workflow

Establish risk management process per ISO 14971.

### Workflow: Create Risk Management Plan

1. Define scope of risk management activities:
   - Medical device identification
   - Lifecycle stages covered
   - Applicable standards and regulations
2. Establish risk acceptability criteria:
   - Define probability categories (P1-P5)
   - Define severity categories (S1-S5)
   - Create risk matrix with acceptance thresholds
3. Assign responsibilities:
   - Risk management lead
   - Subject matter experts
   - Approval authorities
4. Define verification activities:
   - Methods for control verification
   - Acceptance criteria
5. Plan production and post-production activities:
   - Information sources
   - Review triggers
   - Update procedures
6. Obtain plan approval
7. Establish risk management file
8. **Validation:** Plan approved; acceptability criteria defined; responsibilities assigned; file established

### Risk Management Plan Content

| Section | Content | Evidence |
|---------|---------|----------|
| Scope | Device and lifecycle coverage | Scope statement |
| Criteria | Risk acceptability matrix | Risk matrix document |
| Responsibilities | Roles and authorities | RACI chart |
| Verification | Methods and acceptance | Verification plan |
| Production/Post-Production | Monitoring activities | Surveillance plan |

### Risk Acceptability Matrix (5x5)

| Probability \ Severity | Negligible | Minor | Serious | Critical | Catastrophic |
|------------------------|------------|-------|---------|----------|--------------|
| **Frequent (P5)** | Medium | High | High | Unacceptable | Unacceptable |
| **Probable (P4)** | Medium | Medium | High | High | Unacceptable |
| **Occasional (P3)** | Low | Medium | Medium | High | High |
| **Remote (P2)** | Low | Low | Medium | Medium | High |
| **Improbable (P1)** | Low | Low | Low | Medium | Medium |

### Risk Level Actions

| Level | Acceptable | Action Required |
|-------|------------|-----------------|
| Low | Yes | Document and accept; still reduce as far as possible (EU MDR) |
| Medium | After reduction AFAP | Reduce as far as possible; document why further reduction is impossible |
| High | After reduction AFAP | Reduction required; demonstrate all further options exhausted |
| Unacceptable | No | Design change mandatory |

> **EU MDR — AFAP, not ALARP:** For CE-marked devices, risks must be reduced **as far as possible (AFAP)** without economic considerations (MDR Annex I, GSPR 1–4; EN ISO 14971:2019/A11:2021 Z-annexes deviation). ALARP ("as low as reasonably practicable"), which permits cost-benefit weighing in acceptability decisions, is **not an acceptable criterion under the EU MDR** — a notified body will flag it. ISO 14971:2019 itself removed ALARP from the normative text. ALARP may persist in some non-EU jurisdictions (e.g., the UK HSE tradition); if used outside the EU, flag the deviati