Kevin Shao, founder of Sino-American Stephanos Medical Device Solutions, LLC, has about 30 years of industry experience both in the US and China. His experiences cover from Medical Device, Aero Space, Electronics and Metal Working.
Kevin’s experiences and knowledge in both Quality System Management and Lean Six Sigma make him a very strong resource in the highly regulated, data driven environments.
Kevin has been working with both the Global Medical Device leaders such as Medtronic, CareFusion and medical devices companies in China. This provides him a broad understanding of the operations and quality practices of both sides and help him to make the best decisions that fit the culture and requirements from either side.
In his experience within the medical device industry over the last 10 years, Kevin has worked directly with FDA in the areas of audits and new product submissions both in the US and China. He has acted either as the commander of the back room or the point person at the front room with FDA.
Kevin has helped multiple companies in US and China to set up and improve their quality systems to meet the requirements of FDA QMR.
Kevin has provided consulting services to multi-billion revenue medical devices companies as well as small startups in both US and China. His consulting work includes dual diligence and integration of multinational acquisition, quality system development, FDA audits, and operational strategies.
Kevin’s connections and networks in both US and China will help you searching, developing and managing suppliers as well as help you exploring and penetrating markets in both countries.
Kevin also serves as the chairman of membership committee and medical device forum of SABPA (Sino-American Biotechnology and Pharmaceutical Professional Association) OC/LA.
Kevin is a member of OCRA (Orange County Regulatory Affairs Discussion Group).
Kevin is fluent in both English and Chinese.
Kevin has a MS in Mechanical Engineering from the University of Kentucky and a MBA from Illinois Institute of Technology.
Paul S. Kramsky
Mr. Paul S. Kramsky is President of Rockin’ Regulatory, Inc., a regulatory and quality consulting firm specializing in the support of small medical device firms. Prior to this, he was Vice President, Global Regulatory Affairs, for Bausch + Lomb after the successful acquisition of Eyeonics, inc., a start-up ophthalmic medical device company in Southern California where he held the position of Vice President of Regulatory Affairs and Quality Assurance. Previously, Mr. Kramsky was Director of Regulatory Affairs for the surgical division of Bausch & Lomb, which was previously a division of Chiron Corporation. Prior to Chiron, he was employed by Allergan Medical Optics, which was previously a division of American Hospital Supply Corporation.
Mr. Kramsky has more than 30 years of Regulatory Affairs and Quality Assurance experience in the medical device industry and more than 25 years of leadership experience in Regulatory Affairs.
Mr. Kramsky has been an active member of the Board of Orange County Regulatory Affairs Discussion Group (OCRA) where he served as President and Chair of the Program Committee. He was president of the Western Section of the Regulatory Affairs Professional Society (RAPs) prior to its reorganization. He has a Bachelor’s and Master’s degree in Biological Sciences from California State University Fullerton.
Siew Neo has more than 15 years of global medical technology experience with two Fortune 500 companies and two entrepreneurial start-ups, mastering the balance of strategic thinking and swift execution. She has built a track record of growing top-line revenue and bottom-line performance through strategic marketing programs and successfully commercializing medical innovations globally. With her extensive global business experience in Asia, Europe and North America, Siew excels in leading and collaborating with global teams to drive results.
Siew also has extensive experience in digital marketing strategies, customer relationship management (CRM), physician engagement, product development, product portfolio management and global market development. She grew up in dynamic, multicultural Singapore and received her bachelor's degree and MBA in the United States. She is fluent in Chinese and other Asian languages.
Siew is the founder of GlobalBound that specializes in commercializing health technologies in the US