21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.

21 Code of Federal Regulations (CFR) Part 820, also known as the Quality System Regulation (QSR), is part of the United States (US) CFR that establishes the criteria under which medical devices are manufactured. It covers various aspects of the manufacturing process, including design, production, labeling, storage, installation, and servicing of medical devices. The regulation is enforced by the US Food and Drug Administration (FDA), and it aims to ensure that medical devices are safe and effective for their intended use.