We’ll bring your device to market.
AI does the heavy lifting.
FDA experts watch every step.
You've built something that helps people. You shouldn't need a six-figure retainer to navigate the regulatory path to market. Complizen's services combine the Submission Builder platform with hands-on FDA expert review — at a fraction of the cost, in a fraction of the time.
You already know the problem. Here’s the math.
Four steps from kickoff to FDA submission.
We scope your submission
A senior consultant reviews your device, confirms classification and pathway, identifies the predicate strategy, and maps every requirement before a single section is drafted.
Complizen builds the first draft
The Submission Builder drafts every section from your device profile, selected predicates, and applicable FDA guidance. Citations throughout. Nothing invented.
Our FDA expert reviews every section
A senior consultant with direct CDRH submission experience reviews each section, adds comments, suggests language changes, and confirms regulatory compliance before sign-off.
You upload to FDA
You receive a complete, expert-reviewed eSTAR package ready for the FDA portal. We're available for questions during the review period — through clearance.
Two ways to engage.
510(k) Submission Building
The full journey: scope → AI drafts → expert reviews → you submit. 8–12 weeks from kickoff to FDA submission. Fixed fee, tiered by device complexity.
See the 510(k) service →◆ Strategy serviceRegulatory Strategy
A senior consultant reviews your device, recommends the optimal pathway (510(k) / De Novo / PMA / exempt), maps all requirements, and delivers a documented strategy report. The right starting point for any device.
See regulatory strategy →Built for device companies that need expert guidance without the agency overhead.
Small & mid-size manufacturers
Without in-house RA expertise. You’ve built the device — let us build the submission alongside you.
First-time submitters
Navigating your first 510(k) without a roadmap is expensive. We’ve done hundreds. Let’s use that experience.
International companies entering the US
CE-marked but not FDA-cleared? The regulatory culture is different. Our consultants know exactly what CDRH expects.
“Complizen turned what felt like a four-month scramble into a focused sprint. The expert review gave our team confidence we couldn't have built submitting alone.”
“The regulatory strategy work clarified the right pathway in a single conversation. It paid for itself ten times over before we wrote a single section.”