Barbara Whitman

Director - Regulatory Affairs & Quality Assurance

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Ms. Whitman has been working as a Regulatory Affairs and Quality Assurance professional in the medical device industry since 2000. She has worked with companies ranging in size from start-ups to large corporations, developing regulatory strategies for new and existing medical devices. Ms. Whitman has authored domestic and international submissions, obtaining global market clearances and approvals for all device classifications. She has created Quality Management Systems, ensuring device compliance spanning the product lifecycle from concept development beyond commercialization to include post market activities.

Her medical device experience includes collagen vascular grafts, collagen skin grafts, electromechanical surgical staplers, neuromodulation devices containing software, electronic bio compression sleeves, cardiac closure devices, sutures, robotics and surgical meshes. She is devoted to improving patient outcomes through expeditious commercialization of safe and efficacious devices. She holds a Bachelor of Arts degree from Muhlenberg College in Allentown, Pennsylvania.