FormlyAI

What it does

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.

Core 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)

Use cases

• →Achieving EU CE mark certification for medical devices
• →Obtaining US FDA approval/clearance for medical devices
• →Creating and maintaining ISO 13485 compliant QMS
• →Building audit-proof technical documentation
• →Managing document approval and revisions