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Upload your device info
Drop in what you have — specs, intended use, test reports, IFU drafts. Any format. Complizen reads it all into a structured device profile.
AI-native FDA 510(k) clearance
FDA 510(k) cleared,
Half the time.
Half the cost.
Ex-FDA experts and an AI platform built for 510(k)s. Together, they plan, build, and submit your device for clearance.
- Ex-FDA regulatory leads on every submission
- Submission-ready 510(k) in 2–3 months
- One fixed price — no hourly billing, no surprises
Trusted by medical device teams worldwide
Free 30-minute call with a regulatory expert. No obligation.
About
FDA expertise, better with AI
Our team pairs FDA experts with decades of experience with a cutting-edge AI built to transform regulatory work.
AI does the heavy lifting. The expert reviews and manages.
You get to market in a fraction of the usual time and cost.
Pricing is fixed and milestone-based, so our incentives match yours.
How it works
Everything your 510(k) needs — handled end to end.
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Submission plan, auto-generated
Complizen maps your full submission against the latest eSTAR template. Every section, every dependency. You and your FDA expert in the same workspace from day one.
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AI drafts every section
Each section drafted from your device profile, predicates, and applicable FDA guidance. Citations under every claim.
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FDA expert review
Your FDA expert reviews every section as it's drafted. Inline comments, tracked changes, sign-off — fully visible to your team.
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Compiled and ready to submit
Your eSTAR is compiled into FDA-portal-ready format. You upload. We stay on call through the review period.
Want to walk through your device with an expert first? Book a free call — no obligation.
Book your free 510(k) strategy callWhy Complizen
Why device teams choose us for their 510(k).
Faster, lower-cost submissions
AI handles the research, drafting, and assembly. Your 510(k) is submission-ready in 2–3 months, at a fraction of traditional consulting cost.
One fixed price
You know your total cost before we start. No hourly billing, no surprise invoices. We only win when you're cleared.
Real FDA experts
Regulatory leads who sat on the FDA's side of the table review your submission before a reviewer ever sees it.
It's amazing... the regulatory work I can get through now... in a fraction of the time. I can accomodate more clients thanks to Complizen!
Melissa Hall
Founder & Principal Consultant — Statera Consulting
FAQ
Common 510(k) questions, answered.
Is this just another regulatory consulting firm?
No. Consulting firms bill by the hour for a person's time. We pair ex-FDA experts with an AI platform built for 510(k)s — the AI handles the routine drafting and assembly, the experts handle strategy and review. You get consulting-grade judgment at a fraction of the time and cost.
What does working with you look like?
It starts with a strategy call. A senior regulatory lead maps your pathway and predicate, then builds a milestone plan. Our AI drafts the submission; your dedicated team reviews every page with you — all in one workspace, kickoff to clearance.
How does pricing work?
One fixed price, agreed before we start. No hourly billing, no surprise invoices. Payments are tied to deliverables, so our incentives stay aligned with getting you cleared.
How long does a 510(k) take?
Most teams reach a submission-ready 510(k) in 2–3 months — versus the year a traditional engagement often takes. FDA review time is set by the FDA, but a cleaner submission means fewer deficiency rounds and faster clearance.
When should we engage you?
As early as possible. Bringing us in before you lock your predicate or testing plan avoids the most expensive 510(k) mistakes. We also join mid-project — including teams answering an FDA Additional Information request.
What companies do you work with?
Medical device manufacturers pursuing a 510(k) — from startups filing their first product to established OEMs clearing their next. If your device has a viable predicate and a 510(k) pathway, we can help.
Ready when you are
Your 510(k), cleared faster.
Book a free strategy call. We'll map your pathway, your timeline, and your fixed price — no obligation.
Book your free 510(k) strategy call