Works with
ClClaudeNative
CoCodexPackaged
GPGPTPackaged
GeGeminiPackaged
CuCursorPackaged
OpOpenCodePackaged
Risk Management Specialist
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use when user mentions risk management, ISO 14971, risk analysis, FMEA, fault tree analysis, hazard identification, risk control, risk matrix, benefit-risk analysis, residual risk, risk acceptability, or post-market risk.
Optimized workflow
This edition turns the source methodology into a repeatable agent workflow with explicit inputs, checkpoints and deliverables.
Quality standard
- Confirm scope and missing inputs before execution
- Ground decisions in available evidence and preserve source constraints
- Return an actionable result with assumptions, risks and next steps
Agent compatibility
The same core method is packaged for Claude, Codex, GPT, Gemini, Cursor and OpenCode.
Permissions & security
Low risk
Source verified · conversion tested · security signals reviewed