Design Controls
Design and Development Planning - Identifies the interfaces, groups, and activities related to the design development process.
Design Input - A listing of the physical and performance requirements that are the basis for the device design
Design Output - The complete package of specifications that define the final device
Design Review - Ensuring the design is adequate and meets the requirements
Design Verification - Testing to demonstrate the design meets the requirements
Design Validation - Testing to demonstrate the design meets the user's needs and requirements
Design Transfer - Ensuring the design specifications have been properly translated into production specifications
Design Changes - Reviewing all design changes appropriately before implementation
Design History File - Creating a record to demonstrate the design was developed in accordance with an approved plan