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iso14971-risk-analyzer

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Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis

library/specializations/domains/science/biomedical-engineering/skills/iso14971-risk-analyzer/SKILL.md

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# ISO 14971 Risk Analyzer Skill

## Purpose

The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle.

## Capabilities

- Hazard identification questionnaire generation
- Hazardous situation analysis templates
- Risk estimation matrix configuration
- Risk acceptability criteria setup
- Risk control measure tracking
- Residual risk evaluation