One workspace.
Every submission.
From device classification to eSTAR assembly to post-market monitoring — all in one platform. No context switching. No lost work. No surprises.
Built on AI, grounded in regulation
Every answer cites the source. Every suggestion traces back to FDA guidance, 510(k) history, or your own documents.
Tools that talk to each other
Your predicate research feeds the submission. Your risk file links to testing. Complizen connects every step automatically.
For the team, not just the RA lead
R&D, quality, external consultants — all invited into the same workspace with role-appropriate access and full audit trail.
Everything you need, nothing you don’t.
Submission Builder
Your eSTAR, drafted section by section with citation-grounded AI. Pre-flight RTA checks, eSTAR export, and one-click hand-off to an FDA expert.
See Submission Builder →Superagent
Ask any regulatory question. Get a cited answer instantly — from FDA guidance, 510(k) history, and your own documents.
Explore Superagent →Drafting Studio
Start from a template, your own doc, or a blank page. AI fills the gaps — you make the calls.
Explore Drafting Studio →Cloud
Secure, versioned document storage with audit trail and role-based access. SOC 2 Type II. HIPAA-aware.
Explore Cloud →Knowledge
openFDA, MAUDE, guidance docs, classification database — all indexed, searchable, and cited in-product.
Explore Knowledge →Collaboration
Multiplayer editing, shared Superagent threads, and external consultant access — without losing control.
Explore Collaboration →A submission isn’t a document. It’s a workflow.
Complizen connects every step of the submission process into continuous flows. Work done in Knowledge feeds Superagent. Superagent drafts flow into Drafting Studio. Studio output feeds Submission Builder. Everything is integrated.
Research in Knowledge
Pull FDA guidance, 510(k) history, and MAUDE data for your device type.
Ask Superagent
Get classification, predicates, risk signals and testing standards — all with citations.
Polish in Drafting Studio
Refine language, fill gaps, add references — with inline AI assistance.
Build in Submission Builder
Section-by-section eSTAR with automated drafting from your device profile.
Store & review in Cloud
Versioned, auditable, role-gated. Invite your team or a consultant.
Submit or send for expert review
Export your eSTAR, or hand off to Complizen's FDA consultants for a final review.