FDA 21 CFR Part 820 Compliance Made Simple
Cloud-based QMS software built to help medical device and life sciences companies simplify compliance with FDA quality system regulations.
Automated Document Control
Automate document approvals, revisions and version control help ensure current procedures and specifications are followed.
FDA Audit Readiness
Easily track and trace data through integrated workflows and built-in controls.
Ensure FDA Compliance
Electronic signatures, integrated modules and streamlined processes simplify regulatory compliance.
CAPA Management
Streamline corrective and preventive actions with full traceability to nonconformances, audits and customer complaints.
FDA 21 CFR Part 820 compliance for the modern medical device manufacturer
Explore how 21 CFR Part 820 compliance software can benefit your organization
Electronic Signatures and Audit Trails
Risk Management Integration
Design Controls and Change Management
Control product development changes with linked design inputs/outputs, verification/validation and approvals.
Complaint Handling
Nonconformance Tracking
Detect and manage deviations in real time with root cause analysis, disposition tracking and reporting.
Supplier Management
Qualify, approve, and monitor supplier performance with built-in supplier ratings and audit results.
Validation and Cloud Hosting
Pre-validated QMS with available validation documentation, hosted in a secure, validated cloud environment (AWS).
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.
Control of Documents
QT9 QMS Management Review Module
Design Controls
QT9 QMS Product Design Control Module & Design History File Module
Purchasing Controls
QT9 QMS Supplier Evaluation Module
Production & Process Controls
QT9 QMS Inspection Module
Nonconforming Products
QT9 QMS Nonconforming Product Module
Corrective & Preventive Actions
QT9 QMS Corrective Actions Module
Customer Complaint Files
QT9 QMS Customer Feedback Module
FAQ: FDA 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.
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.
FDA 21 CFR Part 820 has 15 subparts labeled alphabetically. They are:
- General provisions
- Quality system requirements
- Design controls
- Document controls
- Purchasing controls
- Identification and traceability
- Production and process controls
- Acceptance (inspections and validations)
- Nonconforming product
- Corrective and preventive actions (CAPA)
- Labeling and packaging controls
- Handling, storage, distribution and installation
- Records
- Servicing
- Statistical techniques
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.
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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Explore quality management resources
QMS Software Validation: Ensuring FDA, ISO and Industry Compliance
From Concept to Market: FDA Approval Process for Medical Devices
Data Integrity: A Critical Component of FDA and ISO 13485 Compliance
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