risk-management-specialist

SKILL.md

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.

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

Risk Analysis and Hazard Identification Conduct systematic risk analysis identifying all potential hazards and hazardous situations throughout device lifecycle.

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. Source: questnova502/claude-skills-sync.

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