Comprehensive risk management skill implementing ISO 14971:2019 methodology for medical device risk analysis
Analyzes medical device risks per ISO 14971:2019 standards for hazard identification and compliance.
npx claudepluginhub a5c-ai/babysitterThis skill is limited to using the following tools:
The ISO 14971 Risk Analyzer Skill implements comprehensive risk management methodology per ISO 14971:2019 for medical devices, supporting hazard identification, risk estimation, risk control, and benefit-risk analysis throughout the device lifecycle.
This skill integrates with the following processes:
iso14971-risk-analyzer:
risk-categories:
- clinical
- electrical
- mechanical
- software
- biocompatibility
- sterility
- usability
probability-levels: 5
severity-levels: 5
acceptability-criteria:
ALARP: true
state-of-art: true
Activates when the user asks about AI prompts, needs prompt templates, wants to search for prompts, or mentions prompts.chat. Use for discovering, retrieving, and improving prompts.
Search, retrieve, and install Agent Skills from the prompts.chat registry using MCP tools. Use when the user asks to find skills, browse skill catalogs, install a skill for Claude, or extend Claude's capabilities with reusable AI agent components.
This skill should be used when the user asks to "create a hook", "add a PreToolUse/PostToolUse/Stop hook", "validate tool use", "implement prompt-based hooks", "use ${CLAUDE_PLUGIN_ROOT}", "set up event-driven automation", "block dangerous commands", or mentions hook events (PreToolUse, PostToolUse, Stop, SubagentStop, SessionStart, SessionEnd, UserPromptSubmit, PreCompact, Notification). Provides comprehensive guidance for creating and implementing Claude Code plugin hooks with focus on advanced prompt-based hooks API.