Tidepool Achieves ISO 13485 Certification for Open Source Quality Management System

Demonstrating commitment to quality and safety while fostering transparency

Tidepool, a nonprofit organization dedicated to empowering the diabetes community through open-source innovation, proudly announces it has achieved ISO 13485:2016 certification from accredited certification body TÜV SÜD America for its open-source Quality Management System (QMS), known as qmsOS. This significant milestone underscores Tidepool’s commitment to maintaining the highest standard of quality and safety while fostering transparency and accessibility within the industry.

Traditionally, QMS frameworks have been proprietary, creating barriers for smaller organizations and startups entering the regulated medical device space. Tidepool’s qmsOS is designed to change that by providing an open, collaborative, and 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,” said Howard Look, Founder of Tidepool. “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.”

A New Era of Open Source Medical Device Development

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

As part of its commitment to industry-wide innovation, Tidepool invites digital health developers, startups, and researchers to explore, contribute to, and adopt qmsOS in their own regulated software development processes.

For more information about Tidepool’s open-source QMS and how it can support SaMD development, visit our latest blog post.

About Tidepool

Tidepool is a nonprofit organization dedicated to creating open-source software that unlocks diabetes data, providing people with diabetes, caregivers, and healthcare providers with tools to make more informed treatment decisions. By fostering a culture of transparency and collaboration, Tidepool is reshaping the future of diabetes technology and digital health innovation. Learn more at tidepool.org. Follow us on Twitter at @Tidepool_org and on Facebook and Instagram.

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