Theresa Brandner
Vice President of Regulatory and Quality
Prior to joining Penumbra, Ms. Brandner was most recently heading the regulatory and quality areas at Boston Scientific SMART (formerly SMART Therapeutics). While at SMART, she was responsible for obtaining Humanitarian Device Exemption (HDE) and CE Mark approvals for SMART's first product, Neuroform and subsequent product modifications, as well as HDE approval for its second product, Wingspan. She has also been responsible for designing and implementing systems and infrastructure for quality (ISO 9001/ISO 13485 and GMP/QSR) along with responsibilities for quality and regulatory compliance. Prior to SMART, she worked at three San Francisco bay area start-ups in the regulatory, quality and operations areas and prior to that worked in manufacturing, regulatory and quality at Interventional Innovations Corp and InStent, Inc. Ms. Brandner brings a great perspective to her 17 years of medical device industry experience including 15 years of quality and regulatory experience having first started in the medical device business as an R&D engineer at St. Jude Medical Inc. She holds a B.S.M.E. from South Dakota State University and a M.S. in Management of Technology from the Carlson School at the University of Minnesota.