| Sumario: | REACH states a complex system of systems that is not only developed by highly multi-disciplinary consortium, but moreover is situated in an environment comprised of a multitude of stakeholders (ranging from governments down to end-users) and external systems. Due to the criticality of personal data and the legal impact of medical, preventive feedback handled by REACH, and considering later CE certification requirements. It is pertinent to follow even from very early, explorative, and conceptual R&D or pre-product development phases onwards a structured systems engineering approach. In this paper, the key aspects, methods, and tools of this approach are presented, and it is shown how they were used in the concept development stage to systematically translate a variety of inputs and analyses (stakeholder workshops, user studies, use case analyses, technology analyses, etc.) into formalized requirements and a holistic system architecture blue print serving as the basis for further work organization in the project.
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