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.
Workflow agent · 510(k)
Your eSTAR,
drafted before your
coffee gets cold.
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 an FDA 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-onFDA expert review
Want a senior ex-FDA expert 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 30-min callSend for Expert ReviewWorking solo? Skip this.
Working solo? Skip this.
Want a senior FDA consultant to review every section before you submit?
One click. A Complizen-affiliated FDA consultant reviews your full submission — section by section, comment by comment — and signs off before you upload. This is the same service as our done-for-you 510(k) track, available to self-builders.
94%
RTA pass rate
on submissions with expert review
The full stack
Superagent
Predicate research and classification power Submission Builder automatically.
Drafting Studio
Open any section in Drafting Studio for deeper editing and template options.
Cloud
Your entire submission stored, versioned, and audit-trailed in Cloud.
Want us to do it for you? →
Full 510(k) building service with senior FDA expert review.