Formly
Formly streamlines EU medical device certification, ensuring rapid CE marking with automated documentation and expert guidance.
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Product Information
What is Formly?
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.
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
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.
Reviews
Primary Tasks For Formly
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Medical devices guide |
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Fda regulations q&a |
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Medical regulation consultation |
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Medical equipment information |
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Pharmaceutical compliance guidance |
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Gdpr compliance |
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Regulatory compliance guidance |
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Process compliance |
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Medical consent forms |
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Ml certification preparation |
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Medical language guidance |
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Certification guidance |
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EU AI Act Q&A |
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Gdpr guidance |
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Compliance automation |
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Best Fit Jobs For Formly
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Medical Engineer |
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75% Impact
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Regulatory Affairs Manager |
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75% Impact
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Medical Assembler |
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Validation Engineer |
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