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fda-qsr-audit-prep

/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.

Manifest SHA-256d3ea7b1450c6eb4a79e947813439ffd21eeafd877001d006ea6a60c045006cfb
  • SKILL.md6,576 bytes

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Public versions