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Medical

[!NOTE] Required license feature: medical (the SOUP-report sub-feature additionally requires soup_report)

The Medical capability extends TrustSource with workflows specific to medical-device software, supporting the documentation obligations of the EU MDR (Medical Device Regulation, 2017/745) and IVDR (In-Vitro Diagnostic Regulation, 2017/746).

What this capability adds

  • MDR / IVDR classification of modules — risk class (I/IIa/IIb/III or IVD A/B/C/D) and intended use captured per module.
  • SOUP reports — generation of Software of Unknown Provenance documentation aligned with IEC 62304, listing third-party components, versions, license and known anomalies.
  • Project-level module-classification template wiring so the medical view is enforced by default for medical-device projects.

📸 Screenshot: a module's classification tab showing the MDR risk-class selector and intended-use field.

📸 Screenshot: the SOUP report export dialog from the outbound section.

Editions

  • SaaS: available with the medical (and optionally soup_report) feature flag enabled.
  • Community Edition: the underlying classification fields are present but the SOUP generation pipeline is not included.