Skip to content

Project #55: Medical Device Regulatory Approval Sunlight License

License

Notifications You must be signed in to change notification settings

OpenICU-org/MedDev

 
 

Folders and files

NameName
Last commit message
Last commit date

Latest commit

 

History

11 Commits
 
 
 
 
 
 

Repository files navigation

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.

About

Project #55: Medical Device Regulatory Approval Sunlight License

Resources

License

Stars

Watchers

Forks

Releases

No releases published

Packages

No packages published