Product Development

A product development process ensures that the design, development, and transfer of a new or modified medical device will result in a product that is safe and effective, and meets user needs and intended use requirements. Design controls begin with the approval of product requirements. Product requirements include the needs of the users, patients, and intended use of the device. Requirements that are essential to the quality, safety, and proper function must be identified. Product requirements are reviewed, approved, and documented in the design history file (DHF). The design and development plan resides in the DHF and any changes made to the plan also reside in the DHF. The program team creates the design and development plan and reviews, updates, and approves the plan as design and development evolves. The design and development plan describes the different elements including their scope and planned approach to fulfill the requirements of each element.