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Shoshana Friedman, RAC

15:30|Session 6 (Stage 3)

Quality Management System in Early Stage Medical Device Companies

Corporate Vice President Regulatory, Clinical and Quality at novoGI and President & CEO at Push-Med

Shoshana Friedman is President and CEO of Push‐Med LLC and has recently accepted the position of Corporate Vice President Regulatory, Quality and Clinical Affairs at novoGI. She has more than 19 years of experience in the fields of regulatory affairs, clinical trials, and quality assurance of medical devices and biotechnology.
Shoshana is a highly respected expert and speaker in international regulatory affairs, clinical trials and quality assurances and is considered a pioneer in the Israeli regulatory affairs community. In 2005, in recognition of her achievements in the field, she was awarded the Richard E. Greco Award by the Regulatory Affairs Professionals Society (RAPS), the highest honor bestowed by RAPS upon outstanding leaders who have made significant contributions in the field. In her many years of activity, Shoshana Friedman has succeeded in educating medical companies in the implementation of regulatory requirements as an integral and critical part of their activity for successful penetration of international markets.
2002‐2006 Mrs. Friedman was Senior Vice‐President, Regulatory and Clinical Affairs, and member of the senior management of Given Imaging (NASDAQ: GIVN). She has been member of the company’s Advisory Board since June 1997 and, as the company consultant, was in charge of obtaining marketing authorization worldwide. Before joining Given Imaging, Shoshana held the position of Managing Director, of Push‐med Ltd., a regulatory consulting firm that she founded. Prior to this position, she was Regulatory, Clinical and QA Director at InStent Ltd., an Israeli medical device company that was acquired by Medtronic Inc. in 1996. Mrs.F
riedman holds a B.Sc. in mathematics and physics from Haifa University, a Business Administration Certificate (with Honors) from Hebrew University, a QA Lead Assessor certification from Bywater, and a Regulatory Affairs Certification (RAC) from RAPS.


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