Kathy Herzog, BSME, is a Regulatory Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. She has worked in the medical device industry for 35 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class III products in the urological, neuromodulation, drug delivery and pain control therapeutic areas.
Prior to joining DuVal & Associates, Kathy worked 26 years at Medtronic in various roles and responsibilities including regulatory strategy planning for US, EU, CAN, and AU submissions (i.e., IDEs, original PMA, PMA supplements, FDA advisory panel meetings, and design dossiers for CE Mark), labeling development, promotional copy review, off-label information management, risk assessment, adverse event reporting, call center management, business process improvement, quality system compliance, SOP development, compliance training, Medical Affairs, and multiple local and global project and program management activities.
Kathy earned a Bachelor of Science in Mechanical Engineering from the University of Wisconsin-Platteville. She has a Green Belt certificate in Lean Six Sigma.