Device classification, simplified.
Medical device classification can be complex, but with Complizen, it’s straightforward and fast.
Simply ask, “What class is my product?” and Complizen’s AI-powered engine does the rest.
What is the classification for
Live data directly from the FDA
Smart Web Search
AI-powered Insights
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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Coming soon
510(k) Assistance
Outline your 510(k) with AI-powered assistance
Minimize errors and optimize your submission quality.
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"
Complizen has transformed my regulatory workflow by streamlining document drafting for clinical studies, SOPs, and contracts, auto-populating FDA-aligned content to save time and boost consistency. An invaluable tool for regulatory professionals.
Leah Gustke
Quality and Regulatory Affairs
Exodus New Ventures
