Intended Use#

Mapping of Requirements to Document Sections#

MDR Class

MDR Section

Document Section


Annex II, 1.1 a) - d), h), i)


ISO 14971:2019 Section

Document Section



IEC 62366-1:2015 Section

Document Section




  • Name: Clinical OpenSaMD Platform

  • Version: v0.1.0

  • Basic UDI-DI: N/A

Clinical OpenSaMD Platform Intended Use#

A Software as a Medical Device platform that supports patient treatment within the following use cases:

  • Clinical decision support within radiotherapy via automated contouring of both target and avoidance structures within the treatment planning workflow.

  • Patient alignment and setup support during radiotherapy treatments via patient surface guidance.

  • Treatment machine gating via patient surface tracking.

  • Alignment of radiotherapy simulation images into breathing phases to support the treatment workflow.

The Clinical OpenSaMD Platform intends to be a platform that supports the safe and effective translation of open source research into Clinical Software as Medical Devices. As such, it is expected that future regulatory submissions will include expansions on the above intended use where the surrounding documentation is also updated accordingly.

Individual Components#

The Clinical OpenSaMD Platform is split into separate components. Each component has its own documentation that covers the following items:

  • Intended medical indication

  • Contraindications

  • Patient population

  • User profile

  • Use Environment including software/hardware

  • Operating principle

The documents for these individual components are the following:

Part of the Body / Type of Tissue Interacted With#

The device is stand-alone software. It does not come in contact with tissue or bodily fluids.

Variants / Accessories#

This is stand-alone software and this is not applicable.