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Debra Cogan , BA

Director
Regulatory Affairs

Redwood City, California

Ms. Cogan joined Arstasis in April of 2010 as Director of Regulatory & Clinical Affairs and later in November 2011 assumed oversight of Quality Assurance. Debra has over 15 yearsÂ’ experience in regulatory, quality and clinical for the medical device industry with large corporations as well as small start-up companies. Her medical device experience includes vessel closure, cardiac surgery, carotid stent and embolic protection systems, and ENT including drug delivery systems. Prior to joining Arstasis, Debra held management positions with responsibilities in regulatory and clinical affairs at Acclarent, Inc., where she designed and implemented innovative regulatory and clinical strategies for a drug delivery system and trail blazed clinical research and subsequent 510(k) clearances for pediatric indications. Acclarent was subsequently acquired by Ethicon, Inc., a Johnson & Johnson Company. As manager of Regulatory Affairs at Abbott Vascular, Debra championed PMA approval for AbbottÂ’s carotid stent and embolic protection system. Debra has extensive experience with implementation of Quality Systems and for bringing Class I/II/III medical devices to market. Debra holds a B.A. in English from the University of Haifa, Israel and an RN from the Carmel Hospital School of Nursing in Haifa.

Contact Information

650.508.1549

740 Bay Rd

Redwood City, California 94063

customerservice@arstasis.com

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