Intended Use — MICROBOTICA#

Platform Positioning Statement#

MICROBOTICA (MICROROBOTics Iterative simulation for Clinical Adoption) is open-source research software. It is not a medical device as defined by EU MDR (EU 2017/745), Article 2(1). It has no medical purpose. It is not intended for clinical use, clinical decision-making, or patient diagnosis. It has not been CE-marked, cleared, or approved by any regulatory body.

MICROBOTICA is a research simulator for microrobot-assisted drug delivery simulations. It provides:

  • A desktop application for interactive visualisation of microrobotics simulations

  • A Python scripting console for parameter manipulation and analysis

  • OpenUSD-based scene management with three-layer composition

  • Pluggable compute and render backends

Layered Responsibility Model#

Layer

Project

Responsibility

1

MADDENING

Physics framework — produces simulation data

2

MIME

Microrobotics engine — domain-specific physics

3

MICROBOTICA

Simulator UI — visualisation, scripting, scene management

4

Commercial Product

CE-marked SaMD — bears all EU MDR obligations

MICROBOTICA does not produce physics data. It receives, displays, and allows interaction with physics data produced by upstream layers. MICROBOTICA’s correctness obligation is faithful rendering: data received from the physics backend must be displayed without corruption or silent modification.

Commercial Boundary Statement#

When a downstream commercial manufacturer incorporates MICROBOTICA into a regulated medical device, MICROBOTICA is classified as SOUP (Software of Unknown Provenance) under IEC 62304. The device manufacturer is solely responsible for:

  • Classifying MICROBOTICA under the applicable software safety class

  • Performing all required verification and validation

  • Assessing MICROBOTICA’s known anomalies for safety relevance in their context of use

  • Implementing any required risk controls or mitigations

  • Maintaining regulatory submissions and post-market surveillance

Cybersecurity Boundary Statement#

MICROBOTICA does not implement security controls for clinical deployment. It does not provide:

  • User authentication or authorisation

  • Encrypted data storage or transmission

  • Audit trail integrity protection

  • Network security controls

When deployed in a clinical context, the downstream manufacturer must implement all required cybersecurity controls per MDCG 2019-16.

AGPL Licence Statement#

MICROBOTICA is licensed under AGPL-3.0-or-later. Downstream commercial manufacturers must ensure their use complies with AGPL terms. The AGPL licence does not constitute a medical device licence or regulatory approval.