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iso13485-audit-prep

/compliance-os: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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The canonical home for this skill is iso13485-audit-prep in alirezarezvani/claude-skills

SKILL.md
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alirezarezvani/claude-skills

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.gemini/skills/iso13485-audit-prep/SKILL.md

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