iso13485-audit-prep

Name: iso13485-audit-prep
Author: alirezarezvani

alirezarezvani/claude-skills/compliance-os/skills/iso13485-audit-prep

25.1k 0PythonDev Tools

PlatformClaude CodeOpenAI CodexGemini CLI

/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.

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