ISO 13485 is the international compliance standard for quality management systems for companies that manufacture medical devices.
Click here to view Micron's ISO Certificate
21CFR part 820 is the U.S. FDA's quality system requirements that includes current good manufacturing practice (cGMP) requirements as set forth in this quality system regulation. The requirements 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.
