FormlyAI
AI software for simplified EU medical device certification.
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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?