Linda Alexander founded Alquest, Inc. in 1993 after working in management and director-level positions in regulatory and clinical affairs for Brennen Medical, Bioplasty and Medtronic. During her career, Linda established worldwide regulatory and clinical strategy and requirements for over 50 devices, including cardiovascular, audiology, interventional vascular, dental, neurovascular, orthopedic, plastic surgery, general surgery, neurology, gastroenterology and urology devices. Linda has obtained clearance/approval for more than 50 premarket notifications; 15 IDE applications; and six PMA applications. Linda is a nationally-recognized and sought-after expert and presenter on clinical and regulatory strategy for medical device companies. She earned a B.S. degree in biology and chemistry (Dean’s List) from Iowa State University, and a M.S. in Technical Communication from the University of Minnesota. |