Fort Hill Group has been invited by the FDA to present some of our research, methods, and lessons learned at the upcoming Physiological Closed-Loop Controlled Devices Workshop on October 13-14 in Silver Spring, MD. We will be presenting lessons learned form applying prioritized risk-based requirements to inform the development of simulator-based training.
More information on the conference and registration information is provided below.
Public Workshop - Physiological Closed-Loop Controlled Devices
The Food and Drug Administration (FDA) is announcing a public Workshop entitled "Physiological Closed-Loop Controlled (PCLC) Devices." The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance evaluation of PCLC systems intended for use in critical care environments. Such devices include closed-loop anesthetic delivery, closed-loop vasoactive drug and fluid delivery, and closed-loop mechanical ventilation.