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AI-powered software for medical device certification and compliance in the EU and US.
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.
Productivity
AI-powered documentation generation; Expert regulatory guidance; Quality Management System (QMS) creation; Technical documentation building; Compliance alerts and automatic updates; Document approval and revision management (eQMS)
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π Stay ahead with AI and receive:
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Access our Free Community and join 400K+ professionals learning AI
β 35% Discount for ChatNode