The next procedure required for the Design process is related to Design Output.
Design Outputs are the results of the design efforts, typically coming together as a product specification. During the Design Input process, or immediately following, these Design Output documents need to be prepared: Component and raw material specifications, product/process specifications, drawings, software code, along with packaging and labeling specifications. The output needs to be directly traceable to the input requirements. Also, outputs from one stage may very well become inputs at another stage.
Design outputs must be comprehensive enough to characterize the device design to allow for verification and validation. Also, design outputs which are essential for the proper functioning of the device must be identified. Typically, a risk analysis tool such as Fault Tree Analysis (FTA) or Failure Mode and Effects Analysis (FMEA) is used to determine essential outputs.
When the Design Output stage is completed, the final output will include, at minimum: the final product itself, packaging and labeling of the product, and the device master record or product specification.
