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.
- skills.sh installs
- 358
- GitHub stars
- 33.2K
- last updated
- Aug 21, 2026
Install
$ npx -y skills add davila7/claude-code-templates --skill risk-management-specialist --agent claude-codeInstalls into .claude/skills of the current project.
Files
Senior Risk Management Specialist
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.
Core Risk Management Competencies
1. Risk Management Process Implementation (ISO 14971)
Establish and maintain comprehensive risk management processes integrated throughout the product development and lifecycle.
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- Repository
- github.com/davila7/claude-code-templates
- Category
- Productivity & Planning
- First seen
- Jun 3, 2026
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