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FormlyAI

AI software for simplified EU medical device certification.

10k 热度 AI医疗 Medical Device Certification CE Marking AI-Powered Compliance Regulatory Guidance Documentation Automation EU Medical Device Regulations Quality Management System
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What is Formly?

Formly is an AI-powered software platform that simplifies the medical device certification process in the EU, enabling fast CE marking through automated documentation and expert regulatory guidance.

How to use Formly?

To use Formly, create an account, choose your plan, and start generating required documentation by answering simple questions.

Formly's Core Features

AI-generated MDR compliant documentation

One-click technical file generation

Tailored roadmap for CE marking

Expert regulatory guidance and support

Formly's Use Cases

#1

Streamline documentation for CE marking of medical devices

#2

Accelerate time to market for software as a medical device (SaMD)

FAQ from Formly

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

How long does it take to get my CE mark?

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

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