Tag Archives: 21 cfr 820.30 guidance

FDA 21 CFR Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820, however, there is no certification process for Part 820 & only compliance with the requirements is assessed.Continue reading “FDA 21 CFR Part 820 Quality system Regulation”