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Formly

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Formly is an innovative AI-driven platform designed to simplify the medical device certification journey in the EU. It accelerates the CE marking process by offering automated, MDR-compliant documentation and expert regulatory support. Users can generate necessary documentation efficiently by simply answering straightforward questions, significantly reducing the time and complexity involved in satisfying regulatory requirements. With features tailored to assist companies navigating the intricacies of medical device regulations, Formly empowers users to focus on their product development while ensuring compliance.
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How Formly Works In 3 Steps?

  1. Initiate Certification Process

    Begin by registering on the Formly platform to access tools.

  2. Input Device Information

    Provide detailed specifications of your medical device for assessment.

  3. Receive Generated Documentation

    Obtain automated, compliant documentation ready for CE marking.

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Formly: Features, Advantages & FAQs

Explore everything you need to know about Formly

Core Features
  • AI-generated MDR compliant documentation
  • One-click technical file generation
  • Tailored roadmap for CE marking
  • Expert regulatory guidance and support
  • Automated compliance updates
  • User-friendly interface
  • Real-time collaboration tools
Advantages
  • Streamlined compliance process
  • Reduced time to market
  • Expert regulatory support
  • Automated documentation generation
  • Flexible pricing plans
  • User-friendly platform
  • Access to up-to-date regulatory information
Use Cases
  • Streamline documentation for CE marking of medical devices
  • Accelerate time to market for software as a medical device (SaMD)
  • Simplify regulatory compliance for startups
  • Assist manufacturers in maintaining compliance
  • Enhance operational efficiency in document handling
  • Facilitate expert consultations for complex regulations
  • Reduce time spent on manual paperwork

Frequently Asked Questions

What is a CE mark and why is it important for my business?

A CE mark indicates that a product complies with EU safety and health regulations, allowing it to be marketed within the EU. It is essential for legal market access and consumer confidence.

How long does it take to get my CE mark?

The time to receive a CE mark can vary, but with Formly's automated processes, it can be significantly reduced. Typically, it ranges from several weeks to a few months, depending on the complexity of the device.

I don't know anything about medical device regulations. Is Formly right for me?

Absolutely! Formly is designed to guide users through the certification process, making it accessible even for those without prior knowledge of medical device regulations.

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