Risk Management Specialist

This is a comprehensive ISO 14971 specialist for medical device companies that walks you through the full risk management lifecycle, from initial hazard identification through post-market surveillance. It covers the complete hierarchy of risk controls (inherent safety by design, protective measures, information for safety) and integrates with IEC 62304 for software risk management and cybersecurity threat modeling. The framework is particularly detailed on documentation structure and maintaining risk management files through design changes. If you're navigating regulatory submissions or audits where traceability matters, the decision trees and verification protocols are thorough. It assumes you're working in a regulated medical device context, so it's overkill for general product risk assessment.

Install to Claude Code

npx -y skills add davila7/claude-code-templates --skill risk-management-specialist --agent claude-code