Imagine

Formly

AI-powered software for medical device certification and compliance in the EU and US.

The AI REPORT pick
Automation
Productivity
Subscription (monthly/yearly)
Overview
ABOUT

Formly is an AI-powered software designed to simplify and expedite the medical device certification process, particularly for startups. It offers tools for creating and managing required documentation, expert regulatory guidance, and AI-backed documentation writing to help companies achieve EU and US medical device compliance and get to market quickly and on budget. Formly supports various standards including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

USE CASE

Productivity

KEY FEATURES

AI-powered documentation generation; Expert regulatory guidance; Quality Management System (QMS) creation; Technical documentation building; Compliance alerts and automatic updates; Document approval and revision management (eQMS)

Meta
Subscription (monthly/yearly)
$1,000+/month
β†’ Go to Pricing Page
Startup (1–10)
United States

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