All manufacturers of medical devices must establish and follow a quality management system to ensure that their products consistently meet federal regulations. A quality management system ensures compliance with quality system regulations by defining responsibilities, procedures, processes, and resources within a company. The quality management system ensures that the same item is made the same way every time, and that the item meets all regulatory requirements.

Quality system regulations are codified in 21 CFR 820. They are also referred to as current good manufacturing practices( cGMPs). 21 CFR 820 is the main regulation associated FDA oversight of medical device manufacturers; however, there are other CFR regulations that apply to specific types of medical devices. In this course the focus will be 21 CFR 820 because it applies to all manufacturers of medical devices.

In this module you’ll learn about

- quality system regulations required by the FDA,
- how a quality management system helps a company comply with federal regulations,
- what makes a good quality management system,
- how STUDENTfacturED’S quality management system works, and
- what can happen without a capable quality management system.