TGFR Consulting LLC
Transforming Medical Device Development
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