Tidepool announced today that it secured a new certification for its open-source quality management system, known as qmsOS.
Palo Alto, California-based Tidepool, a non-profit diabetes data management group, develops open-source technology for the diabetes community. That includes the FDA-cleared Tidepool Loop, a “do-it-yourself” (DIY) automated insulin delivery (AID) system. Recent collaborations include integrations with Abbott and Sequel Med Tech, among others.
The company said it achieved ISO 13485:2016 certification from accredited certification body TÜV SÜD America for qmsOS. It said the milestone underscores its commitment to maintaining the highest standard of quality and safety while fostering transparency and accessibility.
According to a news release, traditional QMS frameworks are proprietary. This creates barriers for smaller organizations and startups entering the regulated medical device space. Tidepool made its qmsOS open, collaborative and adaptable to address those barriers. It says it aligns wit modern software development practices and satisfied regulatory requirements applicable to medical devices.
“Our mission has always been to break down barriers—whether in diabetes technology, regulatory transparency, or industry collaboration,” said Jake Nardone, Tidepool head of quality and regulatory affairs. “Achieving ISO 13485 certification for an open-source QMS is a game-changer. With qmsOS, we are proving that regulatory compliance can be both rigorous and accessible, empowering more innovators to bring life-changing solutions to market faster.”
Tidepool said it invites digital health developers, startups and researchers to explore, contribute to and adopt qmsOS in their own processes.
“Regulatory complexity should not be a roadblock to innovation,” said Howard Look, Tidepool founder. “By making our QMS open source and now ISO 13485 certified, we are providing a valuable resource that others in the industry can leverage to accelerate their own software as a medical device (SaMD) development while maintaining compliance with international regulatory standards.”
