QMSR Inspection Readiness Checklist
25 questions to ask before FDA arrives
A practical self assessment for medical device and IVD companies operating under FDA's Quality Management System Regulation.
FDA RA Group
Inspection Readiness Checklist
25 focused readiness questions with evidence prompts and a simple internal prioritization tool.
Test more than whether the procedures exist.
The checklist is designed to help you evaluate whether your quality system can produce the records, linkages, and implementation evidence needed to support inspection readiness.
Management oversight and quality system integration
Change control, design, supplier, and production controls
Complaints, nonconformance, CAPA, audits, and quality data
A final system integration test using one recent quality event
FDA specific requirements that may apply to your products and establishment
This FDA RA Group checklist is a practical readiness aid. It is not an FDA scoring system and does not guarantee an inspection outcome.
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