Readiness becomes visible through records.
FDA QMSRQMSR transition plan
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
ISO 13485 gap assessment
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Procedure update register
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Training completion record
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Design control evidence index
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Risk management file crosswalk
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Supplier-control evidence map
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
CAPA effectiveness record
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Management review evidence
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Inspection readiness checklist
Keep this as a named evidence object for FDA QMSR: source basis, owner, status, review question, and update trigger should be visible before reuse.
Each object needs review before reuse.
question bankQMSR transition plan
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
ISO 13485 gap assessment
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Procedure update register
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Training completion record
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Design control evidence index
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Risk management file crosswalk
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Supplier-control evidence map
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
CAPA effectiveness record
Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?
Current public sources for FDA QMSR.
official firstThese links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.
FDA Quality Management System Regulation page
Current · FDA source page for QMSR background and implementation information.
Federal Register final rule
2024-02-02 · Final rule amending device quality-system requirements; effective date 2026-02-02.
21 CFR Part 820
Current · Current codified regulation text for Part 820 source checks.