Supported Standards
We support EU MDR, EU IVDR, FDA 21 CFR Part 820 and ISO 13485.Supported Devices
We support all types of medical devices (both EU and USA):- Class I
- Class II
- Class III
Getting Started
Introduction
FormlyAI is the all-in-one platform for medical device certification, regulatory compliance, and quality management systems.
Our expert guidance and automated documentation management make sure you got a best in class Quality Management System compliant
with ISO 13485 and Technical documentation according to EU MDR, EU IVDR, FDA 21 CFR Part 820.
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