ISO 13485 Certification Awarded to Tidepool for Open-Source QMS

Tidepool has achieved ISO 13485:2016 certification from accredited certification body TÜV SÜD America for its open-source Quality Management System (QMS), known as qmsOS.

Traditionally, QMS frameworks have been proprietary, creating barriers for smaller organizations and startups entering the regulated medical device space. Tidepool’s qmsOS, however, aims to buck that tradition by providing an open, collaborative, adaptable system that aligns with modern software development practices and satisfies 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’s 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.”

Lowering Barriers to Regulatory Compliance

Navigating regulatory requirements can be a significant hurdle for emerging digital health companies. Tidepool’s qmsOS addresses this challenge by offering a structured, compliant framework built on widely-used tools like Google Workspaces, Atlassian (Jira and Confluence), and Slack. Designed with agile development in mind, qmsOS allows developers to integrate regulatory best practices seamlessly into their workflows without stifling innovation.

“Regulatory complexity should not be a roadblock to innovation,” Tidepool Founder Howard Look stated. “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.”

ISO 13485 is the internationally recognized standard for quality management systems in designing and manufacturing medical devices. By achieving this certification for an open-source quality management system, qmsOS, Tidepool claims to be pioneering a new paradigm in the medical device industry—one where transparency, collaboration, and shared knowledge drive progress.

Tidepool is a nonprofit organization creating open-source software that unlocks diabetes data, providing people with diabetes, caregivers, and healthcare providers with tools to make more informed treatment decisions.