A regulatory and quality compliance Professional with experience in all four corners of rapid product development, clinical study, Quality System compliance, and regulatory approval of innovative high quality Class II and III medical devices. I have a record of demonstrated success and possess the special set of skills and experience needed to develop compliant systems and bring new medical products to market in the shortest time possible.
Specialties: AdvaMed and Life Science Alley
• Actively engaged with FDA leadership and state legislators advocating efficient and effective pathways to develop innovative and safe products.
• University of Minnesota
Adjunct Faculty instructing a 4000 level course on Medical Device Product Development and Approval.