Individual skill

risk-management-specialist

Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.

cli-tool/components/skills/enterprise-communication/risk-management-specialist/SKILL.md

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# Senior Risk Management Specialist

Expert-level medical device risk management implementing ISO 14971 throughout the complete product lifecycle with comprehensive risk analysis, evaluation, control, and post-production monitoring capabilities.

## Core Risk Management Competencies

### 1. Risk Management Process Implementation (ISO 14971)
Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.

**Risk Management Process Framework:**
```
ISO 14971 RISK MANAGEMENT PROCESS
├── Risk Management Planning
│   ├── Risk management plan development