The COSMIIC System is now open-source certified. This includes a special tag as “Open Healthware,” a newly released certification track for health and medical applications administered by the Open Source Hardware Association (OSHWA). The COSMIIC System can be found with certification ID US002851
The basic certification acknowledges presence of open source licenses and project documentation.
Hardware: CERN-OHL-P-2.0
Software: MIT
Documentation: CC-BY-4.0
The Open Healthware certification acknowledges a more rigorous collection of materials that can allow for replication and use in health (and possibly regulated) applications. For the COSMIIC System, that is Bill of Materials, testing reports, communications with the FDA, and biocompatibility and sterilization information. Note: Certification is separate and replaces no part of any regulatory body’s evaluation of safety and efficacy of the COSMIIC System.
Getting an implantable medical device platform certified as open source is certainly different. Most of this industry is built on closed IP. We think that’s worth changing, and OSHWA certification is a concrete way to show the design files, firmware, and documentation are actually open, not just “available on request.”
Our team is proud to be apart of the growing list of projects involved in the OSHWA’s Open Healthware Initiative supported by their NSF POSE Phase 2 project. Thank you to the OSHWA team for their dedication to representing open source health technologies across all walks of life and fields of use.
