StartupsMid-Market Manufacturers
Complizen Consulting
Senior FDA experts handle your submission end to end, backed by our FDA-trained AI platform. A fraction of the cost and time of a traditional firm.
FDA consulting,
done right.
Complizen helps medical device manufacturers get FDA cleared by combining regulatory experts and AI.
Work with us
Two ways to work with us
EnterpriseConsulting Firms
Complizen AI
The same FDA-trained AI platform our consultants use, built into your own regulatory stack.
How it works
An FDA consulting firm that built its own AI.
Traditional consultants spend most of their week on research. Complizen AI does that same research in minutes. We combine the two, so the work happens at AI speed, with human expert oversight on every decision.
Complizen AI
Your consultant
Your consultant: StrategyComplizen AI: ResearchYour consultant: DecisionsComplizen AI: DraftingYour consultant: ReviewComplizen AI: Double-checkYour consultant: Sign-off
Complizen AI
Your consultant
Your consultant: StrategyComplizen AI: ResearchYour consultant: DecisionsComplizen AI: DraftingYour consultant: Sign-off
Complizen AI
Your consultant: StrategyComplizen AI: ResearchYour consultant: DecisionsComplizen AI: DraftingYour consultant: Sign-off
Your consultant
So what does that get you?
Speed
Complizen AI absorbs the busywork — the searching, the cross-referencing, the first draft of every section. Your consultant spends the week on judgment instead of lookup, so submissions leave in weeks rather than months.
Transparency
No black box. You watch the work as it happens: every task, whether the AI or your consultant is holding it, and exactly where your submission stands. You never have to ask how it is going.
Accuracy
Everything gets triple-checked. Complizen AI checks its own work, your consultant's, and yours — and your consultant checks the AI back. Work passes between them until every little detail is accounted for.
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
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