FDA looks for the following: The quality system: Processes and procedures define and implement to describe how the company addresses medical device regulations. Design History File (DHF): Demonstration of Design Controls throughout the product development process is expected and required. The User Needs of the medical device. Design Output: Roadmap to figuring out how to actually design and develop your medical device. Design Inputs: This define all the performance criteria, requirements, and features of your medical device product.