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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Supported Standards

We support EU MDR, EU IVDR, FDA 21 CFR Part 820 and ISO 13485.

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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.