TGFR Consulting LLC
Transforming Medical Device Development
The Design Worksheet activity creates the detailed mapping from system requirements to the subsystems. During concept development, a preliminary partitioning of the requirements to the subsystems occurred, and that partitioning serves as the basis for this more formal and structured mapping. The process begins with the binning of requirements for subsequent subsystem deployment. The categories …
The development the product begins with the deployment of the design inputs to the subsystems. The following table describes the inputs and outputs of Deployment Process A capability analysis of the manufacturing process and the ability of manufacturing to meet the various performance requirements initiates the process. This analysis drives how the subsystem deployment proceeds …