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Lisa L. Pritchard, BSEEE

VP, Regulatory, Quality, Clinical & Engineering
DuVal & Associates, P.A.

Lisa Pritchard, BSEEE, is VP of Regulatory, Quality, Clinical & Engineering at DuVal & Associates, P.A., and serves as the current Chairperson for the Regulatory Affairs Professionals Society (RAPS) Twin Cities Chapter. She works extensively on worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novo’s, 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.

Prior to joining DuVal & Associates, Lisa executed successful Regulatory, Quality and Compliance strategies at American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings over 30 years of 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. She frequently presents on topics relevant to the medical device industry and is a guest lecturer with the biomedical engineering program at the University of Minnesota. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.

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