21 CFR Part 820 vs ISO 13485

ISO 13485 and 21 CFR Part 820 are both quality management system standards that are significant in the medical device industry. While they share similar objectives in ensuring the quality and safety of medical devices, they have some key differences and serve different regulatory purposes.

ISO 13485: ISO 13485 is an international standard for quality management systems specifically designed for medical device manufacturers and their suppliers. It outlines requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. ISO 13485 focuses on the entire lifecycle of a medical device, from design and development through production, installation, servicing, and disposal.

Key features of ISO 13485 include:

• Emphasis on risk management throughout the product lifecycle.
• Focus on regulatory compliance and meeting customer requirements.
• Requirement for documentation of processes, procedures, and responsibilities.
• Emphasis on continual improvement and customer satisfaction.

21 CFR Part 820 (FDA Quality System Regulation): 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a regulation enforced by the US Food and Drug Administration (FDA) for medical device manufacturers who intend to market their products in the United States. It outlines specific requirements for the design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices. Compliance with 21 CFR Part 820 is a legal requirement for selling medical devices in the U.S. market.

Key features of 21 CFR 820 include:

• Requirement for establishing and maintaining a quality management system.
• Emphasis on design controls, including design verification and validation.
• Requirement for process validation and control.
• Emphasis on documentation and recordkeeping, including device history records.
• Requirement for handling complaints and adverse events.

While ISO 13485 and 21 CFR Part 820 regulations share many similarities, there are also differences, particularly in terms of regulatory requirements and specific emphasis. However, many medical device manufacturers seek compliance with both ISO 13485 and 21 CFR Part 820 to ensure global market access and regulatory compliance. Compliance with ISO 13485 can facilitate compliance with 21 CFR Part 820, but manufacturers must ensure they meet the specific requirements of each standard.

FDA 21 CFR Part 11

FDA CSA 21 CFR Part 11 Compliance