Downstream Integration — Dependency Chain and Responsibilities#

Four-Layer Dependency Chain#

Layer 1: MADDENING          (open source, LGPL, general-purpose framework)
    |
Layer 2: MIME                (open source, LGPL, microrobotics physics engine)
    |
Layer 3: MICROBOTICA         (open source, AGPL, research simulator + registry)
    |
Layer 4: [Commercial Product] (regulated, CE-marked, built by commercial entity)

Layer

Status

Regulatory Obligation

MADDENING

Open-source research tool

None (provides SOUP documentation voluntarily)

MIME

Open-source research tool

None (provides SOUP documentation voluntarily)

MICROBOTICA

Open-source research tool

None (provides SOUP documentation voluntarily)

Commercial Product

Regulated medical device

Full EU MDR manufacturer obligations

Per-Layer Responsibility Details#

Layer 1: MADDENING#

Role: General-purpose JAX-based multiphysics simulation framework.

Provides: Core simulation infrastructure (graph management, JIT compilation, multi-rate scheduling, adaptive timestepping), physics node library, compliance infrastructure (NodeMeta, anomaly registry, @verification_benchmark, @stability).

Does NOT provide: Clinical claims, domain-specific physics for microrobotics, risk management file (ISO 14971).

Layer 2: MIME (this project)#

Role: Domain-specific physics engine for microrobot simulation, built on MADDENING.

Provides: MimeNode ABC, domain metadata (anatomical regimes, biocompatibility, actuation, sensing, therapeutic), GeometrySource protocol, control layer, uncertainty layer, asset schema, B0–B5 benchmark suite, own SOUP documentation and anomaly registry (MIME- prefix).

Inherits from MADDENING: Compliance schema types via maddening.compliance, @verification_benchmark and @stability decorators, HealthCheckNode base class.

Layer 3: MICROBOTICA#

Role: Simultaneously a full robotics simulator (C++17/Qt 6, USD scene authoring, 3D viewport) AND a community registry/leaderboard platform.

Provides: Pre-configured simulation scenarios, interactive visualisation, benchmark execution infrastructure, asset registry with leaderboard, own SOUP documentation (MBOT- prefix).

Layer 4: Commercial Product#

This is the ONLY layer subject to EU MDR. The commercial entity is the EU MDR manufacturer (Article 2(30)) and is solely responsible for all regulatory obligations.

Commercial Responsibility Statement#

The Layer 4 commercial entity is solely responsible for:

  • Establishing and maintaining an ISO 13485 QMS

  • Performing the conformity assessment procedure

  • Engaging and satisfying the Notified Body

  • Building and maintaining the clinical evaluation report

  • Operating post-market surveillance

  • Bearing manufacturer liability

  • Performing SOUP assessment of all open-source layers per IEC 62304

  • Maintaining risk management file (ISO 14971)