Design input document: The purpose is to give the reader a broad general understanding of the system or component. There may be many levels of design documents. It contains the physical and performance requirements of a device that are used as basis for device design. It appropriately addresses needs of user and patient. The purpose is to give the reader a broad general understanding of the device and its components. Design specification document describes the details of either all or specific parts of a design. Establish the product features and its processes, including process handling, sample processing, throughput, reliability, temperature and humidity, power, fluid ingress, sound and calibration.
Based on the Indication for Use, the input documents describe Requirements which will achieve that indication, expanded into Usability, System and Technical Requirements. Design specification will elaborate further details of specifications.