Formly

AI-driven software streamlining medical device certification and compliance in the EU and US.

The AI REPORT pick
Dev Tools
Productivity
Subscription
Overview
ABOUT

Formly is an innovative AI-driven platform that streamlines the medical device certification process, catering especially to startups. It provides comprehensive tools for generating and managing essential documentation, along with expert regulatory insights. With AI-assisted documentation writing, Formly enables companies to meet compliance standards in both the EU and US efficiently, ensuring a swift and budget-friendly market entry. The software is compatible with various regulations, including MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.

USE CASE

Productivity

KEY FEATURES
  • AI-assisted documentation creation
  • Regulatory expertise on demand
  • Quality Management System (QMS) support
  • Technical documentation development
  • Compliance notifications and updates
Pricing
Subscription
$1,000+/month
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