Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She focuses on advising clients on Regulatory, Quality and Compliance topics. Lisa works extensively assisting clients with worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics. Lisa brings over 30 years of experience in working with industry. Prior to joining DuVal & Associates, she executed successful Regulatory, Quality and Compliance strategies at a variety of device companies including American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings extensive experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.