Helping healthcare AI reach patients safely.
I help innovative healthcare companies navigate FDA strategy, AI/ML medical device regulation, and quality systems so breakthrough technologies can reach patients safely.
Regulatory depth, built for AI-driven products.
FDA Strategy
Pathway assessment, De Novo strategy, and direct FDA interactions.
AI/ML Medical Devices
SaMD classification, AI governance, and predetermined change control.
De Novo Experience
First-of-kind authorizations for novel diagnostic technology.
Quality Systems
Design controls, risk management, and cybersecurity documentation.
Global Regulatory Affairs
Multi-market strategy across the US, EU, and beyond.
Startup Leadership
Building regulatory functions from the ground up.
I work at the intersection of healthcare, technology, and regulation.
Over the past decade I’ve worked across diagnostics, software as a medical device, oncology, and emerging AI technologies — helping companies bring innovative products to patients safely and effectively.