Formly

Formly is an AI-powered software platform designed to take the complexity out of medical device certification, especially for startups racing to get to market. It guides you through creating and managing all required regulatory documentation, provides expert guidance on standards like MDR 2017/745, US FDA 21 CFR, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, and uses AI to accelerate the writing of compliance documents. With Formly, you can achieve EU and US medical device compliance faster, on budget, and without needing a full-time regulatory team — giving lean startups the same footing as established players.