fda-qsr-audit-prep
/cs: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.
Details
- Path
- .gemini/skills/fda-qsr-audit-prep
- License
- MIT