Before revision: At a high level, this regulation requires: Establishment of an intended use and design inputs A design plan Periodic design reviews throughout the design process Confirmation that the design outputs conform to the design inputs through: Design verification ("did we design the device right?")
After revision: At a high level, this regulation requires: Design and development planning Design input, including intended use and user needs Design output, including evaluation of conformance to design input requirementsconfirming that the design output meets the design input requirements through: Design verification ("did we design the device right?")