Radiotherapy AI’s QMS and TechDoc
Contents
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 https://github.com/OpenSaMD/OpenSaMD.
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.
Device#
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 https://opensamd.com/. It does not correspond to the
Non Clinical OpenSaMD Platform
software that is downloadable from
https://github.com/OpenSaMD/OpenSaMD.
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 https://opensamd.com/. 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.