Developing safe medical device systems requires good engineering—a disciplined process combined with sound decision-making at every step. In this series of two lectures, Dr. Weininger will introduce the foundational concepts that support the assurance of safety in complex medical technologies. He will describe how safety emerges from the synergy of a robust design and development framework and consistent, informed choices throughout the lifecycle. Topics will include the FDA regulatory framework, the landscape of medical equipment safety standards, and the principles of risk management. Dr. Weininger will also introduce practical tools such as failure mode and fault tree analyses that help structure decision-making and control the chaos of system development. By participating in these two sessions, participants will have a clear view of the standards, processes, and analytical tools that form the foundation of safety engineering in medical systems.