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SOUP Files (Medical)

[!NOTE] Required role: compliance_manager, manager or account_admin Required license feature: medical + soup_report

SOUP (Software of Unknown Provenance) files document third-party software components in medical device projects, as required by IEC 62304 and MDR/IVDR regulations.

What you can do

  • Generate a SOUP list from a module's component data.
  • Map components to SOUP entries with classification and risk assessment.
  • Version and freeze SOUP files at approval time.

📸 Screenshot: the SOUP files list with version and completion status.