Radiotherapy AI’s QMS and TechDoc#

Radiotherapy AI’s Quality Management System and Technical Documentation. Built on top of GitHub and git, OpenRegulatory templates, and Jupyter Book.

All source for the Medical Device, the Quality Management System, and the Technical Documentation are available at

Disclaimer while QMS and TechDocs are under initial development#

This Quality Management System and this Technical Documentation are currently under active development and there is likely to be both mistakes and omissions. The creation of these documents is being shared publicly out in the open in the hope that the development of these documents is able to help other SaMD companies create and regulate their products and help their patients.


These documents corresponds to version v0.1.0 of the Clinical OpenSaMD Platform software. Currently this software is pre-release, and both the software and this document is expected to change before it is available for clinical use. Please reference the version of these documents that is supplied to you with the software itself.

Product Details#

  • Manufacturer Name: Radiotherapy AI Pty Ltd

  • Manufacturer’s Address: 17 Grampian Place Tatton NSW 2650 Australia

  • Software as a Medical Device Identification: Clinical OpenSaMD Platform v0.1.0

Difference to the open source version#

This device corresponds to the Clinical OpenSaMD Platform software that is downloadable directly from It does not correspond to the Non Clinical OpenSaMD Platform software that is downloadable from

The Non Clinical OpenSaMD Platform is provided in the hope that it might be useful but WITHOUT ANY WARRANTY. It is not intended for clinical use, and is instead intended for research use only.

The Clinical OpenSaMD Platform described by this documentation corresponds only to the product that is able to be downloaded from This is the product that is intended to be able to be used for clinical use according to the intended purpose described within this documentation.