Achieve market expansion through expert insights, tailored solutions, and trusted support. Strategic oversight for Class II and III medical devices from a former FDA Lead Reviewer.
I am a Biomedical Engineer with 16 years of experience in Class II and III implants, including 3 years as a Lead Reviewer at the FDA. I don’t just "do RA"—I provide targeted intervention based on how the FDA actually evaluates a submission.
Because I’ve sat on the other side of the desk, I understand the "reviewer’s mindset." I know which gaps trigger a Refuse to Accept (RTA) and which technical justifications actually carry weight during a 510(k) review.
Founders work with me when they need to reduce regulatory risk without hiring a full-time RA head, or when they need a seasoned veteran to defend their technical justifications to the FDA.
Years Experience
Device Specialist
Lead Reviewer