Brauer Device Consultants

Brauer Device Consultants, LLC is a specialized regulatory affairs consulting firm that provides expert guidance to the medical device industry. Led by President Dr. Christine L. Brauer, the company assists clients with navigating complex FDA regulatory requirements, including the preparation and submission of 510(k) premarket notifications, De Novo applications, and Premarket Applications (PMA). The firm also serves as a US Agent for international medical device manufacturers and provides expert witness testimony in litigation related to medical device safety and regulatory compliance. Based in Rockville, Maryland, Brauer Device Consultants supports a wide range of healthcare technologies, from orthopedic bone cements to advanced imaging systems.