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Complizen One

Access the full suite of Complizen features for comprehensive compliance management.
Schedule a demo to see it in action.

Let's talk

FDA Assistant

Interact with our AI assistant for compliance guidance. Ask specific questions and get tailored responses.

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Guidance Document Retrieval

Ask a question and instantly uncover relevant FDA guidance documents, ensuring you always have the right information at your fingertips.

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Standards Navigator

Effortlessly pinpoint the exact standards and test methods your product needs for regulatory approval.

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Unified Database Hub

All the essential FDA databases in one place, empowering you to streamline your regulatory research with precise, AI-powered answers.

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Intelligent Interpretation

Highlight any section you don't understand in the guidance document, and ComplizenAI will provide a clear explanation.

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Multilingual Support

Chat in any language of your choice. Complizen will help you understand all the rules and regulations in your native language.

  • What is Complizen and how does it help my business?
    Complizen is an AI-powered platform designed to simplify FDA compliance for medical device companies. Our platform streamlines the process by providing instant access to FDA guidance documents and offering AI-driven document interpretation, making it easier to understand complex regulations and stay compliant. Complizen reduces the time spent on manual searches and regulatory interpretation, ensuring your compliance process is more efficient and error-free.
  • Who can use Complizen?
    Complizen is ideal for medical device companies, regulatory affairs managers, startups, and consultants who need support with FDA compliance. Whether you're a small business without a dedicated regulatory team or a larger enterprise looking to streamline your compliance workflow, Complizen is built to serve businesses of all sizes.
  • Do I need a regulatory expert to use Complizen?
    No, you don’t need to be a regulatory expert to use Complizen! Our platform is designed to be user-friendly and accessible for teams of all sizes, especially those without dedicated regulatory staff. However, regulatory experts can also benefit from the time-saving tools we offer.
  • How can Complizen assist with 510(k) submissions?
    Complizen can guide you through the 510(k) submission process by helping you identify required components, relevant tests, and applicable standards. It also provides insights from previous submissions to ensure you’re following the most effective path to regulatory approval.
  • How much does Complizen cost?
    Complizen operates on a subscription-based model. To provide tailored pricing for your needs, we recommend scheduling a demo to explore our features and see how Complizen can fit into your regulatory process.
  • What kind of support is available if I need help using Complizen?
    We offer comprehensive support to ensure you get the most out of Complizen. This includes onboarding assistance, live chat support, and a knowledge base to help you navigate any challenges you might face.
  • How do I get started with Complizen?
    Getting started is easy! Simply schedule a demo with our team, and we’ll walk you through the platform’s features and how it can meet your compliance needs. After that, you’ll have full access to Complizen’s powerful tools.
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