Former FDA Lead Reviewer
Accelerate Your FDA Strategy & Market Authorization
Ex-FDA reviewer insight and strategic regulatory advisory for medical device innovators.
- 510(k), De Novo & PMA Submissions
- FDA Pre-Sub Strategy & Meetings
- Substantial Equivalence & Gap Analysis
- Years in Class II & III implants
- 16
- Years as FDA Lead Reviewer
- 3
- De Novo · PMA · Q-Sub
- 510(k)
The Insider Advantage
Regulatory Strategy from an 'Insider' Perspective
Biomedical Engineer
16 years in Class II & III implants
Former FDA Lead Reviewer
3 years inside the review division
RTA Risk Mitigation
Know which gaps trigger holds
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 Refusal to Accept (RTA) hold 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.
Core Services
Premarket advisory, focused where it matters most
Targeted support across every stage of the path to FDA clearance or approval.
- 01
FDA Pre-Submission Strategy & Meetings
Q-Sub package preparation, strategic question framing, and formal FDA meeting leadership.
- Q-Sub package preparation
- Strategic question framing
- FDA meeting leadership
- 02
Premarket Submissions
End-to-end 510(k), De Novo, and PMA dossier compilation, eSTAR formatting, and interactive AI/RTA review responses.
- 510(k), De Novo & PMA dossiers
- eSTAR formatting
- AI / RTA review responses
- 03
Classification & Gap Analysis
Product code & regulation mapping, substantial equivalence comparison, and testing necessity review.
- Product code & regulation mapping
- Substantial equivalence comparison
- Testing necessity review
Why Choose Us
Senior expertise without the full-time overhead
Ex-FDA Insider Perspective
Direct experience from inside the FDA review division.
Targeted & Efficient Execution
Eliminating bloated overhead while focusing on high-impact submission strategy.
End-to-End Submission Support
Continuous guidance from initial Pre-Sub strategy to final clearance.
De-risk your next FDA submission
A 30-minute discovery call to review your device, pathway, and the gaps most likely to slow your review.