Suzanne is a trusted advisor to companies navigating the complexities of medical device regulation by the U.S. Food and Drug Administration (FDA).
Suzanne’s practice focuses on guiding clients in a wide range of activities across the life cycle of their products, including preparing regulatory submissions for new device clearance and approval, advising on the lawful promotion of devices and non-device software products, and evaluating post-market product modifications. Before joining the firm, Suzanne spent over a decade in BigLaw helping medical device stakeholders anticipate, manage, and resolve regulatory risk and challenges.
Suzanne is highly adept at navigating the FDA's shifting landscape for software and digital health products, having advised clients through numerous shifts in the agency’s policies in this space. Known for her strategic insights and collaborative approach, she helps clients identify the appropriate regulatory pathway for their product and successfully bring them through FDA’s process and to market. In addition, Suzanne assists clients with conducting internal investigations involving compliance matters under the Federal Food, Drug, and Cosmetic Act (FDCA), and executing on required remediation and/or training activities.
