Medical device development is a arduous process with rigid requirements that must be met by FDA's approval and other compliances. The lifecycle require a system of phases to ensure safe and effective design control.

There are five phases in developing a medical devices to be cleared for public marketing. The quality system regulation (QSR) governs methods used, facility controls, the design, manufacturing, packaging, labeling, storage, installation, and services of all finished devices. The FDA requires five steps in development: Device Discovery and Concept, Preclinical Research, Path to Approval, FDA Review and Post-Market Safety Monitoring. While medical devices are governed to be developed to meet the requirements for its intended use, there are other general steps in medical device product development that must be followed across the board.