FormlyAI

FormlyAI is a regulatory compliance platform that combines artificial intelligence with human expertise to accelerate medical device certification. It supports major standards including ISO 13485, 21 CFR, EU MDR 2017/745, and IVDR 2017/746. The platform provides a clear certification roadmap covering all necessary steps from certification strategy to post-market surveillance, with modules such as Clinical Evaluation, Risk Management, Traceability Matrix, and User Needs. Designed for medical device companies of any size, FormlyAI claims to help launch products 5-10x faster and save up to $250,000 compared to traditional approaches. It offers dedicated regulatory experts who guide users through the process, ensuring compliance and reducing resource drain. The platform adapts to any product stage and integrates with existing workflows.

Key Benefits

• Accelerates medical device approval significantly (5-10x faster)
• Combines AI and human regulatory expertise
• Covers multiple major certification standards
• Provides structured compliance roadmap