New — QMSR Edition
QMSR Quick-Start Kit
Everything a small device manufacturer needs to know about the Quality Management System Regulation — the FDA rule that replaced 21 CFR Part 820.
Covers the full QMSR text effective February 2, 2026. 45-minute read.
$37One-time purchase
Instant access. PDF format. No subscription.
Buy now — $37 →Instant download. 30-day refund if not useful.
What's included
✓Side-by-side comparison: QMSR vs 21 CFR 820
Every change documented — what moved, what was renamed, what was added, and what it means for your QMS.
✓47-point QMSR compliance checklist
Know exactly where you stand before your next FDA inspection. Walk away with a clear gap list.
✓Gap analysis template
Document your current state against each QMSR requirement. Assign owners. Close gaps systematically.
✓5 QMSR citation scenarios
What investigators are citing manufacturers for under the new rule — and how to avoid each one.
✓QMSR implementation roadmap
90-day plan for small manufacturers transitioning from 21 CFR 820 to full QMSR compliance.
✓Bonus: FDA FAQ responses
Answers to the 12 most common QMSR questions from the FDA — direct from guidance documents.
Who it's for
→QA managers at Class II device manufacturers with fewer than 50 employees
→Contract manufacturers transitioning from ISO-only to QMSR compliance
→RA consultants building QMSR-aligned SOPs and procedures for clients
This kit is for informational purposes only. Not legal or regulatory advice. Consult a qualified regulatory affairs professional for your specific situation.
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