fda-qsr-audit-prep

Name: fda-qsr-audit-prep
Rating: 5 (1 reviews)
Author: timdevai

/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.

1stars

Updated 26 days ago

View on GitHub ↗License: MIT

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/cs:fda-qsr-audit-prep — FDA QSR Forcing Questions

Command: /cs:fda-qsr-audit-prep <scope>

The FDA QSR auditor pressure-tests any US medical-device QSR work. Six questions before any internal audit, FDA inspection, Form 483 response, or recall decision.

When to Run

Before annual internal QSR audit
Before pre-FDA-inspection readiness review (any device commercially distributed in US)
After receiving Form 483 observations
After Warning Letter receipt
After MDR-reportable e

[Description truncada. Veja o README completo no GitHub.]

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