Before 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 requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
After revision: (also known as customer attributes)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 requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")