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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.

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
To learn more about device classification, please refer to our blog post about device classification.