TGFR Consulting LLC
Transforming Medical Device Development
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 …
The development of the final set of requirements closely couples to the development of the architecture. Architecture embodies the breakdown of the system into subsystems, and the final system requirements development should consider the architecture. Many approaches to medical device development advocate for design inputs that are “concept free”, but a concept free approach can …