Design controls ensure the design of safe and effective devices. They require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety. Design controls provide the FDA, and other regulatory bodies, with some assurance that the designed medical device is a safe product that meets quality system requirements and user needs.

Even assuming a company can provide all other appropriate controls when manufacturing devices, without appropriate design controls an unreasonable risk exists that the device will fail to be safe and effective.

Learning Objectives:

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