Formly

Overview

Formly is an AI-powered software platform built for the medical device industry, specifically focusing on regulatory certification and compliance for both the EU and US markets. It assists manufacturers, compliance officers, and quality teams in navigating complex documentation and approval processes. By automating parts of the regulatory workflow, Formly aims to reduce the time and effort needed to bring medical devices to market while maintaining adherence to stringent standards.

How to Use

Sign up, then upload your medical device technical documentation. Follow the guided workflow to input device classification, intended use, and regulatory pathway. Formly helps you compile required documents, risk assessments, and clinical evaluations. Submit the completed file for EU or US certification review, and track progress toward compliance.

Core Features

Use Cases

1. 1 Achieving EU CE mark certification for medical devices
2. 2 Obtaining US FDA approval/clearance for medical devices
3. 3 Creating and maintaining ISO 13485 compliant QMS
4. 4 Building audit-proof technical documentation
5. 5 Managing document approval and revisions

Frequently Asked Questions