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FDA 21 CFR Part 820

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FDA 21 CFR Part 820

We help your company comply with FDA 21 CFR Part 820.

The challenge

The Food and Drug Administration’s (FDA) standards for Title 21 of the Code of Federal Regulations (CFR), also known as the FDA 21 CFR, provide a clear and concise set of regulations.

A specific focus of FDA 21 CFR Part 820, also known as the QSR describes current Good Manufacturing Practices (CGMP), regulations governing the methods used, facilities and controls used for the design, manufacture, packaging, labeling, storage, installation and service of all finished devices intended for human use. These requirements are intended to ensure that medical devices are safe and effective. Medical device manufacturers are subject to FDA inspections to ensure compliance with FDA 21 CFR 820.

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