FDA 21 CFR Part 820 compliance for the modern medical device manufacturer.

Keep track of medical device compliance items and synchronize documentation with anyone, anywhere.

Automate compliance

Eliminate manual processes for medical device manufacturers.

Ensure FDA compliance

Meet food and drug administration requirements

FDA QSR made paperless

Utilize electronic signatures & integrated modules to get your QMS paperless.

Meet CGMP requirements

Meet Current Good Manufacturing Practice (CGMP) with ease.

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See how QT9™ QMS stacks up against 21 CFR Part 820 compliance.

QT9's 21 CFR 820 quality management system is your all-in-one quality management software solution.

Management Responsibility

QT9™ QMS Management Review Module

Subpart B 820.20

Quality Audit

QT9™ QMS Audit Management Module

Subpart B 820.22


QT9™ QMS Employee Training Module

Subpart B 820.25

Design Controls

QT9™ QMS Engineering Change Request Module

Subpart C 820.30

Document Controls

QT9™ QMS Document Control Module

Subpart D 820.40

Purchasing Controls

QT9™ QMS Supplier Evaluation Module

Subpart E 820.50

Production & Process Controls

QT9™ QMS Inspection Module

Subpart G 820.70

Measuring & Testing

QT9™ QMS Calibration Module

Subpart G 820.72

Nonconforming Products

QT9™ QMS Nonconforming Product Module

Subpart I 820.90

Corrective & Preventive Actions

QT9™ QMS Corrective Actions Module

Subpart J 820.100


QT9™ QMS Inspection Module

Subpart G 820.72

Customer Complaint Files

QT9™ QMS Customer Feedback Module

Subpart M 820.198

Frequently Asked Questions: FDA 21 CFR Part 820

What is 21 CFR Part 820?

21 CFR Part 820 is a quality system regulation enforced by the U.S. Food and Drug Administration (FDA) with the goal of ensuring that medical devices are safe and effective for their intended use. The regulation is part of current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers. Compliance with the regulation is required to market and distribute medical devices in the United States.

Why is 21 CFR Part 820 important?

21 CFR Part 820 is important to medical device manufacturers working in the United States since compliance with the regulation is mandatory. Demonstrating compliance proves to the FDA, customers and the public that your company embraces quality processes and can reliably deliver medical devices that work as purported.

What are the requirements of FDA 21 CFR Part 820?

FDA 21 CFR Part 820 has 15 subparts labeled alphabetically. They are:

  1. General provisions
  2. Quality system requirements
  3. Design controls
  4. Document controls
  5. Purchasing controls
  6. Identification and traceability
  7. Production and process controls
  8. Acceptance (inspections and validations)
  9. Nonconforming product
  10. Corrective and preventive actions (CAPA)
  11. Labeling and packaging controls
  12. Handling, storage, distribution and installation
  13. Records
  14. Servicing
  15. Statistical techniques
What is the difference between FDA 21 CFR Part 820 and ISO 13485?

FDA 21 CFR Part 820 is a national regulatory standard enforced in the United States, while ISO 13485 is an international standard outlining medical device quality management criteria. ISO 13485 is not mandatory in the United States, however it is the main quality guideline for several other countries, including much of Europe, Canada, Japan and Australia.


Outside of jurisdiction, the main difference between 21 CFR 820 and ISO 13485 is that ISO 13485 more completely follows a risk-based approach.


In January 2024, the FDA published a final rule amending 21 CFR Part 820. The change will officially bring FDA med device quality requirements more in line with ISO 13485. The revised part 820 is referred to as the Quality Management System Regulation (QMSR) and is scheduled to go into effect on February 2, 2026.

How does QT9 QMS help meet and maintain 21 CFR Part 820 compliance?

QT9 QMS is a highly rated quality management solution geared toward regulatory compliance and efficient systems. We offer more than 23 modules that come standard, including Document Control, Audit Management, Nonconforming Products, Corrective Actions, Employee Training and Customer Feedback, as well as a Device History Record integration.

2024 will also see the release of our all-new Design History File application. All can help medical device manufacturers address FDA 21 CFR Part 820 and other regulations, such as ISO 13485.

Our QMS is backed by free software updates, full customer support, an available ERP integration and Business Intelligence tool. Call today for more information.


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Track all your FDA compliance in one place.

QT9's easy-to-use platform makes traceability and transparency simple.

Built-In Dashboards

Quickly see the status of FDA compliance items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's user-friendly quality management system is FDA 21 CFR Part 11 compliant.

Software Validation

QT9 QMS is validated after each release, and it is in line with FDA QSRs to keep you in compliance with FDA quality system requirements.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Connect multiple operations

Establish and maintain procedures across locations, departments and people.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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