Compliance to Title 21 CFR 820
Learn from industry practitioners and experts about Quality System Regulation (QSR) Requirements for Medical Device Manufacturers for FDA 21 CFR 820 Compliance. FDA 21 CFR Part 820, also known as the QSR, outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance.