The FDA Quality Management System Regulation is in effect. Close your Part 820 gaps before FDA closes them for you.
Instant download after payment. Purchased by QA managers and RA directors at Class II device companies.
FDA investigators are now evaluating manufacturer QMS programs against QMSR — not the old Part 820 standard. The manufacturers most exposed made surface-level adjustments: updated document headers and section references but didn't address the substantive changes.
Three requirements have no Part 820 equivalent: the context of the organization documentation, the post-market surveillance QMS process (820.200), and the full lifecycle scope of risk management. If you haven't done a structured gap analysis, you don't know what you're missing.
Organized to take you from gap analysis to inspector-ready in sequence.
Side-by-side comparison of every Part 820 subpart vs. new QMSR section. 80+ line-item checkpoints. Produces a ranked gap list you can assign to your team this week.
Which procedures need updating, what the old language said, and what the new language must say. Includes required additions for context of the organization, risk management scope, and supplier agreements.
QMSR's biggest structural change: risk management now covers production, post-market, and design — not just design. Maps ISO 14971:2019 requirements to each QMSR touchpoint with implementation templates.
Supplier classification matrix, quality agreement template ready to execute, re-evaluation record template. QMSR 820.160 requires written agreements with critical suppliers.
QMSR 820.200 creates a new QMS-level PMS requirement. Builds your PMS plan, quarterly review template, and annual summary report structure from your existing complaint handling process.
What QMSR-calibrated FDA investigators will ask for — organized by inspection focus area. 483 observation risk matrix. Pre-inspection document readiness checklist. Run this 30 days before any FDA visit.
Each document produces a deliverable — a gap list, a completed agreement, a PMS plan — not a summary of what QMSR says.
Every section references specific QMSR section numbers and ISO 13485 clause numbers. No generic compliance language.
The FDA Inspector Prep Checklist is organized around how CDRH investigators are calibrated post-transition — not a reading of the regulation.
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“I built these templates from 12 years of running a Class II/III medical device manufacturing operation. Every document reflects what FDA investigators actually ask for — not what consultants think they ask for. We use these exact frameworks at AB Medical.”
Joshua Millage, CEO — AB Medical Technologies
“When you've been through enough FDA inspections, you learn what documentation gaps get flagged and which ones slide. These templates close the gaps that matter. We developed them alongside our own QMS buildout and they've held up under audit.”
Rick, Director of Engineering & Regulatory — AB Medical Technologies
Yes — and you're closer than you think. QMSR harmonizes with ISO 13485, so certified manufacturers have the foundation. The toolkit focuses on what QMSR adds beyond ISO 13485 for FDA compliance specifically.
Yes. The documents reference QMSR as amended effective February 2, 2026 — not the old Part 820 QSR.
Markdown — formatted for immediate use with your document control system. Clean, structured, no fluff.
No. This is a practitioner reference toolkit. Consult your regulatory counsel for formal legal compliance opinions.
Get the gap analysis done. Know where you stand before the investigator does.
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