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Agent Skills Guide

risk-management-specialist

published 2026/03/13

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.

📦 Install Skill

Command line install

Install directly with the `skills` CLI.

npx skills add alirezarezvani/claude-skills/ra-qm-team/risk-management-specialist

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