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Kathy Herzog, BSME

Sr Regulatory, Quality, and Compliance Consultant
DuVal & Associates, P.A.

Kathy Herzog, BSME, is a Sr. Regulatory, Quality, and Compliance 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 over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and class III products in the, orthopedic, neuromodulation, urological, and wound dressing therapeutic areas. She is experienced with US marketing submissions (Q-submissions, IDEs, 510(k)s, De Novos, Breakthrough Device Designation requests, Emergency Use Authorizations, HUDs/HDES, PMAs and PMA supplements) and regulatory strategy planning for US, EU, CAN, and AU submissions, labeling development, promotional copy review, Medical Affairs and off-label information management, risk assessment, adverse event reporting, quality system compliance, SOP development, and compliance training.

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