Complete QMS Setup and Review – 21 CFR Part 820

What is FDA 21 CFR Part 820?

FDA 21 CFR Part 820 is a set of regulations issued by the FDA that outlines the Current Good Manufacturing Practice (CGMP) requirements for medical device manufacturers. These regulations mandate that companies establish and maintain a comprehensive quality management system (QMS) to ensure the production of safe, effective, and compliant medical devices. The scope of 21 CFR Part 820 covers all stages of a product’s lifecycle, including design, manufacturing, packaging, labeling, storage, installation, and servicing.

Key Requirements of 21 CFR Part 820

• Design Controls
• Document Controls
• Purchasing Controls
• Production and Process Controls
• Corrective and Preventive Actions (CAPA)
• Device Labeling
• Quality System Records
• Complaint Handling
• Servicing and Installation Activities

Purpose of QMS

A Quality Management System (QMS) for medical devices ensures that products are safe and effective for their intended use. By providing a structured framework, a QMS standardizes and documents processes throughout the entire product lifecycle, from initial design and development to post-market activities. This systematic approach is essential for maintaining consistent product quality and regulatory compliance.

How to Set Up QMS

1. Documentation

   • Quality Manual
   • Medical Device File
   • Document Control Procedure
   • Record Control Procedure

2. Training

   • Ensure employees are well-trained and competent.

3. Implementation

   • Conduct internal audits, review management systems, and ensure supplier agreements meet standards.

4. Internal Audits

   • Perform internal audits before seeking external certification.

5. Certification

   • Obtain certification to legally market your product.

Importance of QMS

• Ensuring Compliance
• Enhancing Product Quality
• Improving Efficiency
• Facilitating Continuous Improvement
• Boosting Customer Satisfaction

Latest Updates: FDA QSR to QMSR Requirements

On January 31, 2024, the FDA issued a final rule amending the Quality System Regulation (QSR) under 21 CFR Part 820 to align more closely with the international standard ISO 13485:2016. This revised regulation is now referred to as the Quality Management System Regulation (QMSR). The key updates include:

• Incorporation of ISO 13485:2016: Aligning FDA requirements with international standards.
• Clarification of Expectations: Establishing additional requirements to ensure consistency with other FDA regulations.
• Effective Date: The rule is effective February 2, 2026

 

Here is our latest training about this transition: