Amy advises medical technology and life science companies bringing novel device, digital health and diagnostic solutions to market. She specializes in providing practical advice consistent with the Food, Drug & Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), and related state laws to support clients in developing their regulatory and commercial strategies.  

Amy counsels clients throughout the product and service lifecycle, from research and development through applicable regulatory authorizations and postmarket compliance. She also frequently supports cross-industry collaborations among pharmaceutical, biotechnology, medical device, clinical laboratory, and traditional technology companies.

Additionally, Amy has supported the day-to-day legal operations of device clients through in-house secondments during periods of transition or particularly high demand on their legal resources. 

Amy was named a Rising Star in Food and Drug Law by Washington DC Super Lawyers for 2019-2020 and by Northern California Super Lawyers for 2022-2025. She speaks regularly at conferences on the regulation of devices and diagnostics.