Common use of Term Definition Clause in Contracts

Term Definition. Intended Use Describes how the device will be used and who the end users will be. This shall include the indicated full range of use for the product. Leverage When a project team utilizes information (components, specifications, deliverables, etc.) from a preexisting project or qualified product. Product Refers to medical devices, as well as, medical drug/device combinations. Includes components, packaging, manufacturing materials, in-process product, finished product, and returned product. Product Configuration (PC) Product Configuration objects describe the physical characteristics of a product. PC object types in cPDM include Specifications, Parts, Routers, Item Master Information, Branch Item Master etc. Product Description (PD) Matrix of Design Inputs and Outputs including references to additional items such as design verification and validation activities, and risk class. Unqualified (UQ) The state, referring to a PC document, that indicates qualification requirements are incomplete, per CFM 13001 and CFM 10369616.