I help healthcare AI companies ship products that work clinically and pass regulatory review.
Physician with expertise in AI software development, FDA regulatory pathways, and clinical validation. I bridge the gap between what engineers build and what clinicians need.
Clinical Validation
Ensuring your AI works in real clinical workflows—not just in demos
Regulatory Strategy
FDA clearance pathways for SaMD, from predicate selection to 510(k) submission
Technical Review
Architecture guidance from someone who understands both the code and the clinic