Where regulatory teams get ahead
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.
Solutions for every team
Whether you're a consulting firm, startup, or enterprise team, Complizen adapts to your specific regulatory workflow and challenges.
“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.
Hear it from our users
Real stories from people who've accelerated their regulatory work with Complizen.
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
Complizen equips our entire team with one reliable source of truth, reducing manual work and speeding up strategy development. It’s become a core part of our workflow.
Leah Gustke
RA/QA Specialist
With Complizen, I can pull the relevant predicate information together in minutes rather than hours. It’s completely changed how I support my clients.
Melissa Hall
Founder & Principal Consultant
