FormlyAI

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.

How to Use

Use Formly to create and manage medical device documentation, access expert regulatory guidance, and leverage AI to automate documentation writing. The platform guides users through the certification process, from determining product risk class to maintaining post-market surveillance.

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)

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

FAQ

How long does it take to get my medical device certification? ZenMux The enterprise-grade large model aggregator with an insurance mechanism for guaranteed AI quality and reliability.