Theresa Brandner
Vice President, Regulatory Affairs
Theresa has over 30 years of management and engineering experience with medical devices in the areas of regulatory, quality, clinical, operations, manufacturing, and R&D. She has been involved with 12 early stage startups, including Penumbra, SMART Therapeutics (acquired by Boston Scientific), C2 Therapeutics (acquired by Pentax/Hoya), and Medina Medical (acquired by Medtronic), as well as working at St. Jude Medical.
She has expertise in neurovascular, cardiovascular, gastroenterology, urology, gynecology, and spine for single use disposable, reusable, and implantable devices. She specialized in the areas of 510(k), Q-Sub, HUD/HDE, IDE, CE Mark, and international approvals and has obtained over 50 device approvals worldwide.
Theresa holds a B.S. in Mechanical Engineering and an M.S./M.B.A. in Management of Technology.
Theresa has over 30 years of management and engineering experience with medical devices in the areas of regulatory, quality, clinical, operations, manufacturing, and R&D. She has been involved with 12 early stage startups, including Penumbra, SMART Therapeutics (acquired by Boston Scientific), C2 Therapeutics (acquired by Pentax/Hoya), and Medina Medical (acquired by Medtronic), as well as working at St. Jude Medical.
She has expertise in neurovascular, cardiovascular, gastroenterology, urology, gynecology, and spine for single use disposable, reusable, and implantable devices. She specialized in the areas of 510(k), Q-Sub, HUD/HDE, IDE, CE Mark, and international approvals and has obtained over 50 device approvals worldwide.
Theresa holds a B.S. in Mechanical Engineering and an M.S./M.B.A. in Management of Technology.
