21 CFR 820 Insights

What is 21 CFR 820?

21 CFR Part 820 is the Quality System Regulation (QSR) established by the U.S. Food and Drug Administration (FDA). It outlines the Current Good Manufacturing Practice (CGMP) requirements for medical device manufacturers. It dictates the methods, facilities, and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. Compliance with 21 CFR Part 820 is mandatory for medical device companies that wish to market their products in the United States.

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What other technologies are related to 21 CFR 820?

21 CFR 820 Complementary Technologies

ISO 13485

ISO 13485 specifies 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 applicable regulatory requirements. 21 CFR 820 also focuses on quality system requirements, so this is strongly complementary.

mentioned alongside 21 CFR 820 in 7% (829) of relevant job posts

ISO 14971

ISO 14971 specifies procedures for risk management, vital for medical device development and compliance with 21 CFR 820's risk analysis requirements, so it is complementary.

mentioned alongside 21 CFR 820 in 10% (330) of relevant job posts

EU MDR

The EU MDR (Medical Device Regulation) establishes requirements for medical devices sold in the EU. While it is a different regulatory framework than 21 CFR 820, it covers similar aspects of medical device development and manufacturing, making it complementary in the sense that manufacturers often need to comply with both.

mentioned alongside 21 CFR 820 in 13% (110) of relevant job posts