Design and development inputs: Inputs relating to product requirements shall be determined and records maintained. The design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patients. These inputs shall include— (a) functional, performance and safety requirements, according to the intended use; (b) applicable statutory and regulatory requirements; (c) where applicable, information derived from previous similar designs; (d) other requirements essential for design and development; and (e) output(s) of risk management. These inputs shall be reviewed for adequacy and approved by designated individual. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs: The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be documented, reviewed, and approved prior to release. Design and development outputs shall— (a) meet the input requirements for design and development; (b) provide appropriate information for purchasing, production and for service provision; (c) contain or reference product acceptance criteria; and (d) specify the characteristics of the product that are essential for its safe and proper use.