Defining (new) requirements for a diagnostic analysis device for integrated serum workplaces

In order to get a long-running project that is in difficulties back on track before the design input, existing requirements for a diagnostic analysis device that have been identified as incomplete, misleading or contradictory are revised, or amended or replaced by newly determined, checked, coordinated and documented requirements. Given the strongly regulated environment in which the project is located, all quality-related and regulatory-related documents and artifacts are generated in an audit-proof manner and transferred to a customer-specific administration environment.