FormlyAI
AI-powered software for medical device certification and compliance in the EU and US.
Medical device certification
Regulatory compliance
EU MDR
Introduction
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.