Model‐Based Systems Engineering as an Enabler for Regulatory Design Compliance

Whether working in the FDA regulated medical field or explosive industrial environments, using model-based systems engineering provides the confidence, traceability and structure to meet regulatory requirements. In addition, the authors propose the methodology to be a means to optimize schedule predictability and development of the most appropriate products. In this paper, the systems engineering process being employed is briefly described and two case studies are explored that make the case for MBSE as a key enabler of efficient design to complex regulations.