Experience seamless quality control with our Integrated Quality Management System. Elevate efficiency and productivity effortlessly. The QMS requirements of the Canadian Medical Devices Regulations are included in the MDSAP. A document outlining the current good manufacturing practices requirements is the FDA 21 CFR Part 820, often known as the Quality System Regulation. A MAVEN integrated quality management system complies not only with ISO 13485, but additional medical device regulatory requirements in many other markets.