Tidepool, a non-profit diabetes data management group, develops open-source technology for the diabetes community, such as the Tidepool Loop, a “do-it-yourself” automated insulin delivery system, which can be crucial to persons managing their diabetes. The company achieved certification under ISO 13485:2016, an international standard for quality management systems for medical devices.

It’s particularly impressive that Tidepool did this as a non-profit. Most (though not all) open source projects that achieve standards certifications are private businesses, because certification is hard work, can be expensive, and is also often the basis of commercial value.

Congratulations to Tidepool for this life-affirming milestone.