Works with
ClClaudeNative
CoCodexPackaged
GPGPTPackaged
GeGeminiPackaged
CuCursorPackaged
OpOpenCodePackaged
Iso13485 Audit Prep
/cs:iso13485-audit-prep <scope> — ISO 13485 QMS audit 6-question forcing interrogation. Design controls + CAPA + post-market focused. Use before Clause 8.2.4 internal audit, MDR / FDA QSR alignment review, or product-launch DHF closure audit.
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