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