Stop your 510(k) from getting RTA'd.
Pre-Submission Audit on your draft. 4-Axis methodology. 5-day delivery. Free.
3 free audits available. Apply by July 15th.
The Rules Didn't Change. The Reviewer's Bandwidth Did.
Your 510(k) is ready and everything is by the book. But CDRH is down 21% in staffing. Reviewers have less time to compensate for ambiguity. A single unclear sentence now triggers an Additional Information (AI) request letter, not because the science is bad, but because nobody has time to decipher it.
The 4-Axis Clarity Methodology
Those AI request letters aren't a science problem. They're a clarity problem. And clarity can be fixed before submission. I do it with my 4-axis methodology, and right now, I do it for $0.
- Terminology Consistency. Device names, predicate names, technical terms identical across all sections.
- Requirements to Tests Traceability. Every performance claim anchored to a named test, a standard, and a quantified result.
- RTA Acceptance Checklist Alignment. Verified line by line against the FDA Refuse to Accept Checklist.
- Device-Specific Compliance. Cybersecurity, SBOM, IEC 62304, AI/ML methodology. Adapted per device category.
How it works
- Apply in 2 minutes. I respond within 10 hours. I tell you if your dossier matches my offer or not. No ghosting.
- Live Google Sheet, if selected. Track every step : pending, in review, severity (Red / Yellow / Green), recommendation.
- Delivery and walkthrough. You receive a 15 to 20 page PDF report on day 5, followed by a 30-minute Loom walkthrough of the findings.
Is this the right fit ?
This is for you if :
- You have a 510(k) draft due in the next 90 days.
- You're a first-time submitter, or your RA lead just rolled off.
- You want a second set of eyes before paying a consultant $40k+.
- Your device falls into : Imaging, IVD, Implants, SaMD, Wearables, or general Class II.
This is NOT for :
- PMA submissions.
- De Novo pathways.
- EU MDR or IVDR work.
- Teams looking for regulatory strategy advice (study design, predicate selection, risk file architecture).
My current work
Public Audits
I independently audited 3 publicly cleared 510(k)s. No client relationship, no compensation. The method, applied in the open.
Get your free audit
I respond within 10 hours.
Quick questions
No. I review for clarity, not regulatory strategy. I don't tell you what to submit. I tell you what a reviewer will struggle to read.
Yes. Before any document changes hands. Standard mutual NDA, or yours if you prefer.
I respond within 10 hours either way. If your dossier isn't a fit, I tell you why. You can re-apply with a future submission.
Me. Personally. No outsourcing, no AI rewriting your text, no junior analyst behind the curtain.
None. I need 3 real case studies to validate my method. You're the validation, I'm the work. After the audit you owe me nothing. If you see value afterwards, we can discuss a full audit later. If not, you walk away with a clearer dossier.
A consultant tells you what to write. I read what you already wrote, and tell you where a reviewer will get stuck. Different job. Cheaper. Faster. Complementary, not competitive.
About me, if you really wanna know
Silence is underrated. Most consulting pages tell you about decades of experience, certifications, and conference talks. I don't have any of that. What I have is time, obsession, and an outsider's eyes.
I'm Rémy Martinez. I'm 17, based in Switzerland, and I started reading FDA 510(k) Summaries long before I ever thought about turning it into a service. The gap between what's submitted and what's clear kept me up at night. I launched MartinezClarity in early 2026 and published 3 public audits of cleared 510(k)s, so you can see how I work before you ever consider sending me yours.
I'm not a regulatory consultant. I won't tell you how to design your study, choose your predicate, or build your risk file. I read what you've already written with one question in mind : would a reviewer at minute 4 of page 23 understand this without re-reading the previous section ? Most of the time the answer is no, and the fix is smaller than you think.
Two things shaped how I work.
Full Maltese hold.
Calisthenics.
I trained for years to hold the full Maltese. It's a planche variant that requires roughly 600 hours of progressive overload across the shoulders, lats, and core. You don't fake it. You don't shortcut it. You show up every day and the body either holds the position or it doesn't. That's the same discipline I bring to reading a 200-page 510(k) draft : page by page, section by section, no skimming.
One of mine.
Photography.
I shoot for the same reason I read submissions. Composition is a clarity problem. Either the eye lands where it should, or the frame is noisy. Photography taught me to look at a page the way a reviewer does : where does attention go, what's loud, what's missing, what's redundant ? Most submissions fail the same test a bad photo fails. Too much in the frame, not enough hierarchy.
If that sounds like the kind of second pair of eyes that would help, you can apply above. If you'd rather work with someone who's been doing this for 20 years, I get it, and I can recommend a few.
Rémy