This is the home repo for MedDev, an attempt to construct a new kind of free-libre open source license aimed specifically at medical devices. The COVID-19 pandemic has demonstrated the need for open, transparent devices which are both suppy-chain resilient and fully tested under normal regulatory regimes. In order to build an system of for-profit and non-profit firms that support such devices to alleviate want now and in the future, we believe a license that encourages a new kind of sharing is required: one that allows re-use of device designs and test documentation by forcing publication at the time of reuse for regulatory clearance.
Our current legal draft is here. We are actively seeking attorneys to help us complete this draft.
We have a set of loose notes as a working document.
We can of course give editing privileges to people who join this project. We are interested in volunteers with regulatory (especially FDA) experience, governement policy and health experience, and, in particular, lawyers with experience with free-libre open source licenses.
The diagram in the directory may give you a general idea of our approach.
Based on some work by Sabrina Merlo of OSMS, I wrote this essay proposing a new kind of FDA clearance. This is independent of the license, but it is related as a motivational work, so I'm linking it here. It has been submitted to the Day One Project.
Thanks to Pierre Lonchampt for sharing some of his knowledge with us.