More than Device Classification
Streamline your medical device regulatory journey with intelligent automation and expert guidance.
510(k) Strategy in Minutes
AI-guided intake, pro-code selection, predicate analysis, risk signals and a tests & standards plan.
Accelerated Timelines
Reduce prep time from weeks to days with automated research and structured outputs you can reuse.
Predicate Analysis
Instantly find similar devices, compare characteristics, and trace every claim back to FDA records.
Collaborative Workspace
Work as a team with comments, version history and audit logs. Every section is source linked.
Post-Market Intelligence
Monitor adverse events and recalls in real time. Turn post-market signals to concrete risk mitigation strategies.
Compliance Tracking
Keep milestones and rationale organized. Create a clear trail that reviewers and auditors can follow.
Powered by FDA Data Sources
7,000+
Product Codes
170,000+
510(k)'s
55,000+
PMA's
23M+
MAUDE Events
56,000+
Recalls
661
Guidance Documents
Every insight is backed by source citations for defensible decision-making
Complizen is built on FDA datasets your team already trusts, including Product Classification, 510(k), Recalls, MAUDE, TPLC, PMA, and more. Every insight is backed by source citations so you can justify decisions internally and externally.
Teams use Complizen to reduce classification errors, prepare submissions with higher confidence, and eliminate hours of manual cross-referencing between CFR, Product Codes, and 510(k) summaries.
We designed this workspace specifically for medtech startups, RA consultants, and SME regulatory teams that need accuracy without heavy enterprise tools.
Real FDA Data
Updated Daily
Trusted by
RA Teams &
Consultants
“What used to take weeks of digging now takes minutes with Complizen.”
Leah Gustke
RA/QA Specialist | Exodus New Ventures
Private AI
Customer data is never used to train AI models — your information remains yours.
Compliance By Design
Our platform is architected with regulatory best practices (SOC2) at the core.
End-to-end encryption
All customer data is encrypted in transit and at rest with industry-standard AES-256.
Audit Ready
Every action is logged for traceability and compliance support.