FormlyAI

Medical device conformity made easy

FormlyAI is the next generation of regulatory support for MedTech. We provide medical device and software as medical device companies with a Virtual Chief Regulatory Officer that automates the hardest parts of global compliance and certification. By combining AI-native automation with ex-FDA authority, we help manufacturers clear EU MDR/IVDR and FDA hurdles with a level of agility that traditional consulting cannot match. Our platform doesn't just manage compliance - it accelerates the entire lifecycle of medical innovation, ensuring that global market access is a business driver, not a barrier.