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fda-qsr-audit-prep v1
/compliance-os:fda-qsr-audit-prep [scope] — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
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/compliance-os:fda-qsr-audit-prep [scope] — FDA 21 CFR 820 (QSR / QMSR) audit 6-question forcing interrogation. Post-Feb 2026 substantially harmonized with ISO 13485. Use before annual internal QSR audit, pre-FDA-inspection readiness, or Form 483 response.
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d3ea7b1450c6eb4a79e947813439ffd21eeafd877001d006ea6a60c045006cfb- SKILL.md6,576 bytes