01
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.
Build your 510(k) eSTAR
in half the time.
Complizen Submission Builder takes your device profile and works through every section of a 510(k) — scoping requirements, drafting language, tracing citations, and pre-flighting against FDA’s Refuse-to-Accept criteria.
- eSTAR-native export
- RTA pre-flight checks
- Expert review available
01Submission Cover LetterComplete
04Indications for UseComplete
05Device DescriptionComplete
06Predicate Comparison TableComplete
07Substantial Equivalence NarrativeComplete
14Performance Testing — BenchDrafting
15Biocompatibility (ISO 10993-1)Pending
18Sterilization & Shelf LifePending
AI suggestion
“4 of your 5 predicates cited ASTM F2182 for flex testing. Want me to draft that paragraph using K211045 language as the base?”
What it handles
01 · Scope
Pathway & scope definition
Input your device. Get your classification, product code, applicable special controls, user fees, and submission pathway — cited and ready to defend.
02 · Requirements
Automated requirement analysis
Complizen maps every applicable FDA requirement, standard, and guidance to your submission type and device category — nothing missed, nothing invented.
03 · Drafting
Section-by-section AI drafting
From indications for use to substantial equivalence narrative — AI drafts each section from your device profile and predicate history, with full citations.
04 · Traceability
Full submission traceability
Every claim links to a source document, every section maps to an eSTAR field, every version is logged. Your audit trail is built as you write.
How it works
From device profile to FDA submission, in 5 steps.
Drive it yourself in one workspace — bring in a regulatory expert when you need one.
02
Submission plan, auto-generated
Complizen maps your full submission against the latest eSTAR template. Every section, every dependency. Your team works in one shared workspace from day one.
03
AI drafts every section
Each section drafted from your device profile, predicates, and applicable FDA guidance. Citations under every claim. You review and refine in the workspace.
04
Optional add-onRegulatory expert review
Want a regulatory affairs professional to review every section before you submit? Add it on as a service. Or skip it and keep review on your own team — the platform works either way.
Add full expert review service →05
Compiled and ready to submit
Once every section is signed off, your eSTAR is compiled into FDA-portal-ready format. Export and upload, with the full audit trail.
Want to see the platform on your specific device? We'll walk you through it — no commitment.
Book a demoWhy Submission Builder
Faster, centralized, and AI-powered end to end.
What you get when AI drafting, FDA knowledge, and your team’s workflow live in one place.
Speed
Ship submissions 2× faster
AI drafting and predicate research collapse weeks of work into days. Teams typically move about 60% faster than the traditional consulting timeline.
Centralized
Everything in one place
Your whole team works in the same workspace. Track progress, comment inline, and stay on the latest version. No more email threads or version hunting.
AI copilot
Always on call
Trained on current FDA guidance and your device profile. Ready 24/7 to draft, cite sources, research predicates, or answer questions. Like a senior expert at your side at any hour.
Automation
Automate the busywork
Predicate research, section drafting, citation hunting, RTA checks. All handled automatically. You focus on the device, not the paperwork.
Two ways to get to submitted
Do it yourself — or let us handle everything for you.
Same AI engine. Same workspace. Different level of expert involvement — your choice.
Do it yourself
You’re on this page
Your team runs the submission in Complizen. AI handles classification, predicate research, requirements mapping, section drafting, citations, and RTA pre-flight. Your RA team reviews, signs off, and submits — bring your own consultant if you want one, or add expert review as a service.
Let us handle everything
510(k) Submission service
A regulatory affairs professional builds your entire 510(k) on the same AI engine, with end-to-end review and section-by-section sign-off. Fixed fee. You show up for FDA — we do the rest.
See the service →The full stack