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FDA compliance, simplified.

Complizen simplifies FDA compliance for medical device companies, offering affordable and quick guidance through a user-friendly AI platform.

Discover how Complizen uses advanced AI to navigate complex regulations effortlessly. 

510(K) Management Feature
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Effortless compliance with AI precision

Discover why industry leaders trust CompliZen to streamline compliance for medical devices, cosmetics, and food products.

All-in-one compliance solution

Document management, real-time alerts, and automated reporting in a single, user-friendly platform.

Powered by cutting-edge AI

AI interprets complex FDA regulations, provides real-time updates, and offers intelligent, precise guidance to streamline your compliance process.

Save time and money

Automate routine compliance tasks, reduce manual effort, and minimize costly delays, allowing your team to focus on core business activities.

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Instantly Access
FDA Documents

Ask your question, get relevant documents.

Save time, stay focused, and accelerate your path to market.

Clarify regulations with ease

Highlight, ask and understand.

Turn regulatory puzzles into actionable insights.

Coming soon

510(k) Assistance

Outline your 510(k) with AI-powered assistance

Minimize errors and optimize your submission quality.

Invest your time in your business, not in navigating regulations.

Comprehensive Compliance Support

Streamline your FDA facility and product registrations, and benefit from our expert US Agent services—all through the intuitive Complizen platform.

Facility Registration

Use Complizen to manage FDA registration of your facilities effortlessly. Our software guides you through each step, ensuring complete and accurate submissions.

Product Registration

Simplify the FDA registration of your products directly through the Complizen platform. Our intuitive process handles all necessary documentation and submissions for you.

US Agent

For foreign businesses, Complizen offers US Agent services, acting as your official representative to the FDA. Our platform facilitates seamless communication and compliance.

Our Clients

What Our Clients Say

"Efficient and Effective"

Since integrating Complizen into our compliance workflow, we've seen remarkable improvements in efficiency and accuracy. The AI's ability to quickly retrieve and interpret FDA documents has significantly reduced our compliance burden.

Director of Regulatory Affairs
at Bio Health Company

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