Cybersecurity in the Crosshairs: Legal and Financial Risk in FDA-Regulated Medical Devices

• August 15, 2025

The FDA has begun urging manufacturers to treat cybersecurity risk management as a material business concern. Hal Porter, Director of Consulting Services, Clearwater, speaks with Allyson Maur, Associate, McGuireWoods, about the implications of the FDA’s growing focus on cybersecurity as a core component of medical device safety and financial risk and what that shift means for legal, compliance, and risk professionals. They discuss how manufacturers and providers should navigate these expectations, how legal teams can prepare for regulatory scrutiny, and how cyber risk in the device ecosystem is quickly becoming a board-level issue. Sponsored by Clearwater.