Robert Mosenkis, MSE, PE, CCE
President
Robert Mosenkis, a recognized expert in medical device testing and regulation, has managed CITECH's operations since 1989. Mr. Mosenkis directs CITECH's testing services to the medical device industry worldwide, usually working with manufacturers that seek clearance from the U.S. Food and Drug Administration to market new medical devices. He also manages CITECH's FDA-accredited third-party 510(k) review services to the medical device industry. Mr. Mosenkis has been a speaker and consultant on medical device design to avoid user error and has organized international conferences on human factors in medical devices.
Prior to CITECH, Mr. Mosenkis had a 21-year career with ECRI, the world's largest independent organization dedicated to healthcare technology assessment. Starting in 1968 as senior project engineer, he rose to Vice President of Research and Development in 1988. Other positions included Vice President for Publications, and Editor in Chief of Health Devices, a monthly journal acclaimed by hospitals throughout the world. Mr. Mosenkis also directed ECRI's medical device testing programs and participated in the technical review of projects and manuscripts.
Mr. Mosenkis has written for many ECRI publications, including a monthly column on medical device problems, and contributes to other periodicals and books. Mr. Mosenkis served as consultant to the U.S. General Accounting Office in its oversight studies of the Food and Drug Administration. In earlier ECRI projects, he developed model electrical safety and inspection/preventive maintenance programs for hospitals and participated in Health Devices product evaluations and hazard investigations.
Before joining ECRI, Mr. Mosenkis was a design engineer with the Cardiovascular Engineering Group of RCA's Medical Electronics Division. Prior to that, Mr. Mosenkis was a design engineer with Philco Corporation and the Univac Division of Sperry Rand. He was awarded a patent for a computer circuit design.
Mr. Mosenkis is a member the Electrical Safety Committee of the Association for the Advancement of Medical Instrumentation (AAMI); the Editorial Board of Health Devices; the Editorial Advisory Board of Medical Device & Diagnostic Industry; and the U.S. Technical Advisory Group to the International Electrotechnical Commission (IEC) Technical Committee 62 (Electrical Equipment in Medical Practice). He was a member of the Medical Device Standards Board of the American National Standards Institute (ANSI).
Mr. Mosenkis received his Bachelor of Electrical Engineering degree from the City College of New York in 1958. He received the Master of Science degree in Electrical Engineering from the University of Pennsylvania in 1966, and has taken credit courses in human anatomy and physiology. He is a Registered Professional Engineer and a Certified Clinical Engineer.
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Robert Mosenkis, MSE, PE, CCE
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