It's amazing... the regulatory work I can get through now... in a fraction of the time. I can accommodate more clients thanks to Complizen!
Melissa Hall
Founder & Principal Consultant — Statera Consulting
FDA · Co-pilot · For Medical Devices
Regulatory
Made Perfect
Today’s leading medtech teams trust Complizen to elevate their regulatory craft and navigate FDA with confidence
Complizen is AI designed for med-device regulatory affairs. Sharpen your expertise on a trusted platform that lets you focus on high-value work.
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+
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