Dr. Joseph Kozikowski will present a lecture at SAIT on achieving safety and leadership in advanced electromedical devices.
NATICK, MA – April 15, 2012 – Clinivation, Inc. announced today that clinivation Founder and CEO Joseph Kozikowski, M.D. will present a lecture at the Samsung Advanced Institute of Technology (SAIT) in Giheung, Korea on achieving safety and leadership in advanced medical devices.
As an authority on the development and commercialization of advanced medical technology, Dr. Kozikowski will share his perspectives in a lecture entitled “Achieving Global Leadership in Advanced Electromedical Devices- Lessons from the U.S. FDA’s Evolution of Premarket Benefit:Risk Determinations.”
The lecture will address how the astronomical complexity of contemporary advanced electromedical devices has exposed the limitations of traditional regulated quality management systems, how prescriptive checklists are now impossible to conceive prospectively, and how the satisfactory demonstration of conformant execution of processes only amounts to indirect evidence of product safety. The U.S. FDA’s evolution from checklists to process conformance to benefit:risk determinations will be presented, and contemporary approaches to medical device safety- including safety assurance case methodologies and visual modeling of software- will be introduced.
The audience will include Samsung research, development, and business executives. The lecture will be held in conjunction with The Forum for Innovative Technology, from 3:00 to 5:00 p.m. on April 25, 2012 at the Main Lecture Hall, Samsung Advanced Institute of Technology, Giheung, Korea. Further details are available in English and Korean printed and online announcements, available through the Chief Technology Office, Samsung Advanced Institute of Technology.
Following the presentation, Dr. Kozikowski will be available for discussions and meetings to discuss the topics in greater depth. A reception will follow in Giheung.
A reception will follow in Giheung.
Quotes & Commentary:
“It is an honor to have been invited to present this lecture, and I thank Dr. Hyung-Joo Kim, Dr. Kinam Kim, and SAIT for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.
Samsung Advanced Institute of Technology (SAIT) is Samsung Group’s central R&D organization, established in 1987 as the incubator for cutting-edge technologies. SAIT has been focusing on researching core technologies that would create new business opportunities and concentrating on the development of new products. SAIT’s research fields consist of future IT, new materials & device, bio, and energy.
SAIT also functions as the Chief Technology Office (CTO) for Samsung Group, including Samsung Electronics, establishing the Group’s overall R&D outlook and strategy.