FormlyAI
An AI-powered software for medical device certification and compliance, suitable for both the European Union and the United States markets.
Introduction
AI-powered software for medical device certification and compliance in the EU and US.
What is Formly?
Formly is an artificial intelligence-based software designed to simplify and accelerate the medical device certification process, particularly for startups. It provides tools for creating and managing necessary documents, expert guidance on regulatory compliance, as well as AI-assisted document drafting services. These features help companies ensure compliance with EU and US regulations regarding medical devices, enabling them to bring their products to market quickly and within budget. The standards supported by Formly include MDR 2017/745, FDA 21 CFR in the United States, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
How to use Formly?
Use Formly to create and manage medical device documentation, obtain expert guidance on regulatory matters, and leverage AI technology for automated document preparation. This platform assists users throughout the certification process, from identifying the risk categories associated with their products to ensuring proper monitoring after they are released onto the market.
The core functions of Formly
AI-driven document generation
Expert supervision and guidance
Creation of a Quality Management System (QMS)
Technical documentation preparation
Compliance reminders and automatic updates
Document Approval and Version Management (eQMS)
Expert supervision and guidance
Creation of a Quality Management System (QMS)
Technical documentation preparation
Compliance reminders and automatic updates
Document Approval and Version Management (eQMS)
Visits：10
Updated：2026-11-07
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