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FDA QMSR 21 CFR Part 820 Evidence & Implementation Kit

$249.00
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FDA QMSR 21 CFR Part 820 · Medical device quality management, made adopt-ready · Evidence & Implementation Kit
Meet the FDA Quality Management System Regulation (21 CFR Part 820), without decoding the regulation yourself.
Every requirement handed to you as an adopt-ready control, the quality system and management responsibility through design controls and production to CAPA, complaints and records, with the evidence FDA examines.
Ready in a weekend, not a quarter.

Here is the honest situation. The FDA Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference with FDA-specific additions. It requires a quality management system, management responsibility, resource and competence management, design controls, production and process controls, identification and traceability including UDI, purchasing controls, complaint handling and FDA reporting, corrective and preventive action, control of nonconforming product, internal audits, and document and record control. A manufacturer with a legacy Part 820 system but no ISO 13485-aligned QMSR is exactly where organizations fall short.

This Kit removes the guesswork. It is the FDA Quality Management System Regulation (21 CFR Part 820) written as adopt-ready controls you personalize in a weekend, with the evidence FDA examines.

What you get, the moment you buy

18
Requirements as adopt-ready controls. Every requirement, written so you personalize and apply it.
18
Evidence-they-examine checklists. For each control, exactly what FDA examines, plus where organizations fall short, so you close the gap first.
1
Control Matrix, pre-built. Every requirement in a working spreadsheet, ready to record status, owner and evidence location.
1
Gap & Readiness Assessment. Score each requirement and the workbook returns your readiness as a single percentage, and exactly what to fix next.

Grounded in the FDA Quality Management System Regulation (21 CFR Part 820). Editable Word and Excel files.

The QMSR raised the bar
The QMSR harmonises Part 820 with ISO 13485, changing the quality system. This Kit builds its requirements into controls with the evidence FDA asks for.

What one control looks like

This is the opening control, where the program begins. All 18 are built to this depth.

QMS-1 Confirm applicability and scope SCOPE
Put this control in place

Determine and document how 21 CFR Part 820, the Quality Management System Regulation harmonised with ISO 13485, applies to [your organization name]'s medical devices and the parts of its quality system in scope, so scope is clear and the organization can evidence its determination.

Requirement note.

The FDA Quality Management System Regulation (21 CFR Part 820) incorporates ISO 13485:2016 by reference with additional FDA requirements for medical device manufacturers.

Evidence FDA examines
  • A QMSR applicability assessment
  • Scope of the quality system
  • Records of the determination
Common finding they raise: Applicability and scope under the QMSR are not assessed.

Why this is not another template pack

  • The evidence is the point. A requirement you cannot evidence is a gap waiting to be found. This tells you what FDA examines and where organizations fall short, for every requirement.
  • The specifics built in. The requirement's distinctive requirements are written into the controls, not left generic.
  • Built on a mapped compliance corpus, not one person's opinion, from a graph of thousands of controls across standards.
  • It compounds. This work shares its shape with related security and safety frameworks, so it feeds your wider program.

Who buys this

Medical device manufacturers and their quality, regulatory and operations teams. Whether it is a first QMS build or a QMSR-transition uplift, you save weeks and walk in with your design controls, CAPA, complaints, production and records controls structured.

By the end of the weekend you will have
✓  An adopt-ready control for all 18 requirements
✓  A completed control matrix
✓  The evidence FDA examines
✓  Your core controls in place
✓  A readiness percentage and a fix list
✓  The highest-risk gaps closed

Common questions

Is it really editable? Yes. Word and Excel files you own and adapt. No portal, no subscription.

Is this the same as the old Part 820? No. The QMSR harmonises Part 820 with ISO 13485:2016 plus FDA additions. This Kit covers the harmonised requirements.

Does it cover CAPA and complaints? Yes. Corrective and preventive action and complaint handling are each built as controls, alongside design controls.

What if it is not for me? A 30-day money-back guarantee.

Do not face FDA with requirements you cannot show.
Every requirement is fast to adopt with the Kit. It is instant, and it is guaranteed.
Add it to your cart and be ready this weekend.

Instant digital download · 30-day money-back guarantee · The Art of Service Pty Ltd, GPO Box 2673, Brisbane QLD 4001 · support@theartofservice.com

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