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MedDev: Medical Device Regulatory Approval Sunlight License

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, tranparent 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 believ 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.

We are currently using a commentable google doc as our working document.

Early Efforts

This project is in its infancy. We (Marc Jones and Rob Read for now) are drafting our thoughts via a shared google doc for now.

The diagram in the directory may give you a general idea of our approach.

A Related Motivation

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.

Acknowledgments

Thanks to Pierre Lonchampt for sharing some of his knowledge with us.