We were overwhelmed and didn't know where to start. Complizen gave us the confidence to move forward, knowing we weren't missing something critical along the way.
Ángel Enríquez, Ph.D.
Founder, CEO — EmboaMed
The Platform
Months of regulatory work,
handled in days.
More than 200 medical device teams around the world use Complizen to handle their FDA regulatory work — from classification to clearance.
Why medical device teams choose Complizen.
FDA data, not guesswork.
Every AI answer traces back to FDA guidance, 510(k) history, MAUDE, the classification database, or your own documents.
End-to-end coverage, in one workspace
Classification through post-market, with your whole team in the same place — multiplayer collaboration, centralized version history, and an automated project dashboard so everyone sees what's drafted, reviewed, and ready.
Purpose-built for medical devices
Designed around the specific standards, regulations, and workflows medical device teams actually run — not a generic legal AI adapted for healthcare.
Helping teams stay focused and see measurable results
Medical device teams use Complizen
From startups to top-50 OEMs
200+
Hours saved per submission, on average
Across 510(k) filings in 2025
50+
Regulatory workflows automated
From strategy to clearance
20+
Regulatory data indexed and searchable
Ready for our AI Agents to use
100M+
Inside the platform
Six tools. One regulatory workflow.
Superagent
Your AI FDA expert. Ask any regulatory question and Superagent dispatches specialized subagents — returning cited, defensible answers. The engine behind every other tool.
Learn more
Drafting Studio
AI-assisted document writing. Start from a template, upload your draft, or begin blank. AI fills the gaps and traces every citation.
Learn more
Submission Builder
Your eSTAR, drafted section by section. AI works from your device profile, runs RTA pre-flight checks, and exports a portal-ready package.
Learn more
Knowledge
Every FDA database, guidance document, and international standard — unified, searchable, and cited in-product.
Learn more
Collaboration
Multiplayer document editing, shared Superagent threads, external consultant access, and a full audit trail.
Learn more
Cloud
Secure storage for every document, every revision. AES-256, SOC 2, 21 CFR Part 11. Role-gated access and full audit trail.
Learn more
Also inside the platform
Classification, predicate research, and Q-Sub prep — the same six tools, pointed at three more jobs.
Device Classification
Know your classification in minutes.
Complizen learns your device, queries the FDA classification database, and returns your Class (I, II, or III) and product code — plus every applicable special control with 21 CFR citations, the FDA guidance for your device type, and the submission pathway and current user fee that follow from it. Every result ships with a cited rationale document you can share with FDA, your quality system, or your investors.
Predicate & Device Research
Find your predicate. Or your competition.
AI-ranked predicate shortlists, scored by similarity across intended use, technology, and patient population — plus De Novo precedent search, PMA precedent research for Class III devices, and MAUDE adverse-event and recall history on your candidate predicates. Every session ends in an export-ready comparison table, formatted for Section 5 of your 510(k).
Q-Sub Preparation
Get FDA on your side before you submit.
Superagent helps you decide whether a Pre-Submission meeting is worth having, drafts the Q-Sub package — device description, proposed intended use, pathway, and testing strategy — and helps formulate the questions most likely to get a useful answer. After your meeting, upload FDA's written response and Superagent updates your submission plan accordingly.
How it all connects
A submission isn’t a document. It’s a workflow.
Complizen connects every regulatory job into one workflow. Superagent — our AI agent network — researches FDA’s databases (openFDA, MAUDE, classification, guidance docs) and your documents, then dispatches subagents that draft, reason, and cite. Every tool talks to every other tool automatically.
01
Research in Knowledge
Pull FDA guidance, 510(k) history, and MAUDE data for your device type.
02
Ask Superagent
Get classification, predicates, risk signals, and testing standards — all with citations.
03
Polish in Drafting Studio
Refine language, fill gaps, add references — with inline AI assistance.
04
Build in Submission Builder
Section-by-section eSTAR drafted from your device profile.
05
Store and review in Cloud
Versioned, auditable, role-gated. Invite your team or a consultant.
06
Submit or send for expert review
Export your eSTAR — or hand off to Complizen's FDA consultants for a final review.
Enterprise-grade security & privacy.
Built for the firms FDA already trusts. AES-256 at rest, TLS 1.3 in transit, SOC 2 aligned controls, role-based access, and comprehensive audit logs — all included by default. And your data is never used to train AI models.
See our trust page →SOC 2
Aligned controls
AES-256
Encryption at rest
TLS 1.3
Encryption in transit
SSO & MFA
Enterprise auth
Zero training
On your data