Mark DuVal, J.D., is President & CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
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.
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.
Bryan specializes in advising medical device, pharmaceutical and nutritional supplement companies on FDA law, regulations and guidance. His practice includes providing advice in areas of advertising and promotion, compliance, formal and informal appeals and strategic 510(k) submissions.
Aaron has a wide-range of regulatory experience including Medical Device Reporting, Corrective Action/Preventive Action (CAPA), 510(k) submissions, PMA supplements, technical file reviews, advertising/promotional reviews, notified body audits, and FDA inspections.
Patrick Johnson, BS, is a Regulatory Consultant who focuses on advising clients on medical device, pharmaceutical and combination product Regulatory and Compliance topics.
Jessica has successfully managed global regulatory submissions and approvals in the U.S., Europe, Canada, and Australia, including 510(k)s, PMAs, Technical Files, and design dossiers. Her therapeutic area expertise covers surgical masks, infusion disposables, orthopedic implants, patient monitoring software, and more. She has over 10 years of experience working in the medical device industry leading regulatory strategies, submissions, and quality compliance for Class I, II and III products.
Greg Spar is a Software & Design Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. He focuses on advising and supporting clients on software and hardware design requirements to comply with requirements for regulated industries.
Scott Lambert is an Engineering Design Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. He focuses on advising and supporting clients on hardware and software design to comply with requirements for regulated industries.
