iso14971-risk-analyzer
About
This skill implements ISO 14971:2019 risk management for medical devices, enabling hazard identification, risk estimation, and control measure tracking. It provides templates for risk analysis, benefit-risk documentation, and report generation throughout the device lifecycle. Use it within Claude Code to automate and structure compliance with medical device risk management standards.
Quick Install
Claude Code
Recommendednpx skills add a5c-ai/babysitter -a claude-code/plugin add https://github.com/a5c-ai/babysittergit clone https://github.com/a5c-ai/babysitter.git ~/.claude/skills/iso14971-risk-analyzerCopy and paste this command in Claude Code to install this skill
GitHub Repository
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