Downstream Integration Guide — MICROBOTICA#

Status: Skeleton — full content in Phase 3.

Four-Layer Dependency Chain#

MADDENING (Layer 1, LGPL-3.0)
    ↓
MIME (Layer 2, LGPL-3.0)
    ↓
MICROBOTICA (Layer 3, AGPL-3.0)  ← this project
    ↓
Commercial Product (Layer 4, proprietary)

Commercial Responsibility Statement#

The commercial product manufacturer (Layer 4) bears all EU MDR obligations. MICROBOTICA provides documentation artifacts to support the manufacturer’s regulatory submissions, but does not itself make any clinical claims or bear regulatory obligations.

SOUP Assessment Support#

MICROBOTICA provides the following artifacts to support downstream SOUP assessment under IEC 62304:

  • docs/validation/known_anomalies.yaml — complete anomaly registry

  • docs/validation/soup_package.md — SOUP package document

  • CHANGELOG.md — version history with verification status

  • CITATION.cff — version identification

Full Content (Phase 3)#

The complete downstream integration guide, including:

  • Detailed SOUP assessment procedure

  • Risk management integration guidance

  • Verification evidence mapping

  • Configuration management requirements

will be developed in Phase 3 when commercial integration becomes relevant.