Because the quality system regulations apply to many different types of devices, the regulations provide a broad framework that all manufacturers must follow.

Manufacturers develop a firm-specific quality management system to ensure compliance with those parts of the quality system regulations that are applicable to their specific products and operations. The quality management system establishes methods and procedures to design, produce, and distribute medical devices that are safe and effective.

The FDA has prescribed the essential elements of a quality management system. An adequate and properly implemented quality management system has a high likelihood of preventing unsafe products from being designed, manufactured, or distributed.

The quality management system should be commensurate with the risk presented by the device, the complexity of the device and manufacturing process, and the size and complexity of the manufacturing facility.

Learning Objectives:

- 1.3 - Explain how a quality management system helps a company meet the guidelines from regulatory bodies.