What 'Predetermined Change Control' Actually Means for Your AI Model
A practical read on how the FDA's PCCP framework changes the way adaptive AI/ML diagnostics get authorized — and maintained.
Head of Regulatory Affairs · PharmD
Helping healthcare AI reach patients safely.
I help innovative healthcare companies navigate FDA strategy, AI/ML regulation, quality systems, and global regulatory pathways — so good technology actually reaches the people who need it.
Areas of Focus
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.
About
I’m a regulatory affairs leader specializing in AI-powered healthcare technologies.
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.
Featured Writing
View All WritingNotes on regulation, AI, and building well.
De Novo Is Not a Fallback. Treat It Like a Strategy.
Why the De Novo pathway deserves a seat at the table from day one, not just when 510(k) options run out.
Building a Regulatory Function Before You Think You Need One
The case for hiring regulatory leadership earlier than instinct says you should — and what that role should own first.
Speaking & Events
Conversations on AI, regulation, and innovation.
DIA Regulatory Affairs ConferenceAI/ML Medical Device Regulation
HealthTech Founders SummitBuilding Regulatory Functions in Startups
Diagnostics Innovation PodcastAI Governance in Practice