TGFR Consulting LLC
Transforming Medical Device Development
Taking a concept and developing the requirements, the design inputs
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 …
The operational risk analysis forms the basis for the use case development. During the operational and functional analysis portion of the risk analysis, use cases have been identified and linked to the failure modes. This analysis needs to be formalized into use cases that can be translated into requirements. In most definitions of a use …
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs. The overall work flow is as shown in the following Over the next several weeks we will discuss each of the activities, starting with the use case development
Early Concept Confirmation Concept confirmation follows identification of the final concept. In this step, the concept is realized as drawings, models or other tangible artifacts, and feedback from users and customers gathered to confirm that the concept developed truly meets the user and customer needs. Throughout the concept development process, user and customer needs have …