Design Control Training for Drug-Device and Other Combination Products
Because of the additional complexity and risks associated with combination products, a design control plan should be put in place from product inception. Once established, the plan can be used to determine the adequacy of the design requirements and confirm that there are no negative interactions between its individual parts. The plan will also provide assurance that those parts, when combined, result in a combination product that performs as expected. In this class, you will learn how to apply control to the design process to ensure that your combination product meets user needs, intended uses, and specified requirements.