chenxihuang1028-a11y/risk-management-specialist

Claude Skill: ISO 14971:2019 medical device risk management — risk analysis, evaluation, control, FMEA tooling, post-production surveillance

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chenxihuang1028-a11y/risk-management-specialist

Skill Claude CodeCodex

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…

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