Mark DuVal, J.D., is CEO of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
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.
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.
Chris focuses his consulting practice on the intersection of clinical evidence, regulatory requirements, and payer coverage policies to ensure research programs can support product approval requirements and demonstrate value to payers and providers. A biostatistician by training, he has over 25 years of experience in the medical device industry and has successfully negotiated numerous study designs with FDA and several OUS regulatory agencies.
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.
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.
Mark focuses his consulting practice on regulatory strategies including approval pathways and performance data requirements, submissions, and quality compliance for Class I, II, and III medical devices. He advises clients on product development activities, submission preparation, FDA reviewer negotiations. Mark brings over 30 years of experience in the medical device industry.
Scott brings over three decades of experience in IT, digital solutions, and operational leadership to his role as Chief Operating Officer at DuVal & Associates. With a proven track record of driving organizational efficiency and growth, Scott excels in overseeing complex operations, developing strategic plans, and maximizing team productivity.
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.
