Elicitation of user needs for the production process and production facilities of IVD sensors

Classic requirements and system engineering methods are used. Context, process and system models are modeled in Lucidchart and archived in an ALM tool (codebeamer). Requirements are collected in the ALM tool. This guarantees complete traceability of the elicitation process and proper documentation of the requirements. A technical chapter structure is created based on the production process and the system context, which serves as a guide for interviews with users in order to understand tasks and restrictions. The requirements derived from this are recorded in the form of user stories. Particularly important is the associated rationale, which describes the reason or purpose for a requirement and thus represents the justification for the requirement. The advantage of this approach is that the user and stakeholder needs are documented in the problem space without restricting the solution space in the subsequent concept and design phase.