01
Upload your device info
Drop in what you have — specs, intended use, test reports, IFU drafts. Any format. Complizen reads it into a structured device profile.
Solutions · 510(k) Submission Building
Your 510(k),
AI-built. Project-managed.
Building a 510(k) is months of regulatory legwork. Complizen automates the busywork — so your team gets to market roughly 2× faster, with every stakeholder in one workspace and a live dashboard showing what's drafted, reviewed, and ready to submit.
340+
Hours saved per submission on average. Across all 510(k) filings in 2025.
94%
RTA pass rate on submissions built and reviewed in Complizen.
8wk
Median time from kickoff to FDA submission for Class II devices.
What Complizen automates
From classification to submitted eSTAR, Complizen handles the regulatory legwork.
Regulatory intelligence
Always current on what FDA expects.
Complizen maps your device to the right classification, product code, applicable 21 CFR sections, special controls, FDA guidance documents, recognized consensus standards (ASTM, ISO, IEC), and the latest eSTAR template — automatically. You start with what FDA wants, not a blank slate.
AI drafting
Every section, every protocol, drafted from your device.
Device description, indications for use, predicate comparison table, substantial equivalence narrative, performance testing summary, risk analysis seeded from MAUDE history, test protocols, software documentation, labeling — drafted from your device profile, with citations under every claim.
Project orchestration
Run as a managed project, not a spreadsheet.
A live dashboard shows every section's status, owner, and blocker. Engineers, RA, labs, consultants, and expert reviewers all work in one workspace with threaded comments, section-level sign-offs, version locking, and a full audit trail.
Audit-ready by default
Defensible the whole way.
RTA pre-flight against FDA's current Refuse-to-Accept criteria, full traceability matrix linking every claim to its source, eSTAR-native export, and an audit trail built as you write — ready for FDA, notified bodies, and the next submission.
How it works
From device profile to submitted eSTAR.
Five steps. One workspace. AI doing the regulatory heavy lift.
02
Submission plan, auto-generated
Complizen maps your full submission against the latest eSTAR template. Every section, every dependency. A live project dashboard for your team from day one.
03
AI drafts every section
Each eSTAR 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-onTeam review & sign-off
Your RA team reviews and signs off section by section — inline comments, tracked changes, version locking. Want a senior ex-FDA expert to review with you? Add it as a service.
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 Complizen on your specific device? We'll walk you through it — no commitment.
Book a 30-min callTwo 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
Submission Builder platform
Your team runs the submission in Complizen. AI handles classification, predicate research, requirements mapping, section drafting, citations, project management, and RTA pre-flight. Your RA team reviews, signs off, and submits — bring your own consultant if you want one.
See the platform →Let us handle everything
510(k) Building service
Complizen plus a senior ex-FDA expert builds your entire 510(k). Same AI engine, plus end-to-end expert review and section-by-section sign-off. Fixed fee. 8–12 weeks. You show up for FDA.
See the service →