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

Streamline documentation for CE marking of medical devices

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