risk-management-specialist

Quick Review

Excellent specialized skill for ISO 14971 medical device risk management. The description clearly articulates when to invoke this skill (risk planning, assessments, control verification, file maintenance). Task knowledge is comprehensive, covering the complete risk management lifecycle with specific methodologies, decision trees, and integration points with software (IEC 62304), cybersecurity, and human factors. Structure is well-organized with clear hierarchies and process flows, though the single-file format is dense; still appropriate given the interconnected nature of risk management. Novelty is solid: ISO 14971 implementation requires specialized regulatory knowledge and complex cross-functional coordination that would consume significant tokens for a general CLI agent. The skill provides frameworks, decision trees, and integration protocols that meaningfully reduce cost for medical device companies. Minor improvement opportunities: could reference more specific automation scripts for routine tasks, and the cybersecurity/software sections could be slightly more detailed given their growing regulatory importance.