Simbionix Appoints Director of Newly Established Regulatory Affairs Department

Cleveland, OH, USA: Simbionix USA Corporation, the world’s leading provider of medical education and simulation training products for medical professionals and the healthcare industry, is pleased to announce the appointment of Dr. Yael Friedman to Director of the newly established Regulatory Affairs Department.

Simbionix has leveraged its leading position in the healthcare training and education market to expand its activities into the clinical market, having recently received market clearance for the PROcedure Rehearsal Studio™ software, the next generation in “patient specific simulation”. With a PhD in Biology and twenty years research experience in leading universities in the USA and Israel, Dr. Friedman has been with Simbionix for the past ten years as Chief Scientist for Medical Projects. Dr. Friedman’s deep understanding of the potential and requirements of medical simulation has led to a long track record of successful activities in the simulation market. By working closely with key opinion leaders, medical societies, and professional associations to create meaningful, effective and scientifically validated simulation products, her efforts have resulted in the publication of some 130 validation papers on Simbionix products, demonstrating and validating their value in medical education. For the past two years Dr. Friedman has also taken the lead in the company’s regulatory activities, successfully navigating the process of obtaining an FDA 510(k) clearance for Simbionix’s new and exciting PROcedure Rehersal Studio™ software.

“Yael represents the core values of Simbionix, namely creating innovative products that improve patient care and outcomes while responding to the market’s ever increasing simulation needs,” said Gary Zamler, CEO of Simbionix. “We are very pleased we are able to bring our innovative simulation technologies to the clinical market and have established the Regulatory Affairs Department to better serve the market, by accelerating future PROcedure Rehersal Studio™ products under development. To the best of our knowledge Simbionix is the only simulation company to be granted FDA 510(k) clearance for a simulation technique. We are building on our successful experience in the healthcare training and education market and expanding it to create simulation based products for the clinical market as well. Yael is the ideal person to lead our global Regulatory Affairs activities as we expand into the clinical market.”