Tidepool Earns ISO 13485 for Open Source QMS
Tidepool, a nonprofit organization focused on advancing diabetes care through open-source innovation, has achieved ISO 13485:2016 certification for its open-source Quality Management System (QMS), known as qmsOS. The certification was awarded by TÜV SÜD America, an accredited body known for its rigorous standards. This milestone marks a breakthrough in the digital health space, as it’s one of the first times a fully open-source QMS has earned such recognition.
ISO 13485 is the global standard for quality management systems used in the design and manufacture of medical devices. Earning this certification signals that Tidepool’s qmsOS meets strict international requirements for safety, effectiveness, and compliance—offering the same credibility as traditional, proprietary QMS platforms but with the added advantage of being open and freely accessible.
Redefining Quality in Medical Device Innovation
Historically, quality management systems in the medical device world have been proprietary, costly, and complex. These traditional models can create high barriers to entry, particularly for startups, researchers, and small organizations developing regulated software like Software as a Medical Device (SaMD). Tidepool’s qmsOS is a direct challenge to that model—open, transparent, collaborative, and aligned with today’s agile software development practices.
“Our mission has always been to break down barriers—whether in diabetes technology, regulatory transparency, or industry collaboration,” said Jake Nardone, Head of Quality and Regulatory Affairs at Tidepool. “Achieving ISO 13485 certification for an open-source QMS is a game-changer. With qmsOS, we’re proving that regulatory compliance doesn’t have to be exclusive or expensive. It can be rigorous and accessible at the same time.”
The significance of this achievement goes beyond Tidepool itself. By releasing qmsOS as an open-source resource, Tidepool is enabling other digital health developers to adopt a compliant QMS framework without the cost and constraints of commercial solutions. This means that smaller teams, startups, and nonprofits can more easily enter the regulated medical space and bring innovative tools to patients faster.
Built for Modern Teams and Agile Workflows
Tidepool’s qmsOS is designed for teams that work with modern tools and agile methodologies. It integrates with platforms like Google Workspaces, Jira, Confluence, and Slack, making it flexible and easy to implement. This practical, modular approach allows developers to embed regulatory processes into their day-to-day operations, rather than treating compliance as a separate or obstructive burden.
“Regulatory complexity should not be a roadblock to innovation,” said Howard Look, Tidepool Founder. “By making our QMS both open source and ISO 13485 certified, we’re giving others a real head start. SaMD developers now have a proven framework to build from, one that’s already aligned with international standards and adaptable to their workflow.”
This approach lowers the barrier to regulatory adoption while maintaining the integrity and rigor required by global health authorities. Developers and companies can use qmsOS to streamline the development of safe, compliant, and user-focused medical software—accelerating time to market without compromising quality.
A Model for Open Collaboration in Health Tech
The certification of qmsOS ushers in a new era of openness in medical device development. By sharing its QMS framework openly, Tidepool is promoting a more transparent and collaborative approach to regulatory compliance—an area historically dominated by proprietary systems and guarded processes.
Tidepool encourages other organizations to not only adopt qmsOS but to contribute to its ongoing improvement. Through community engagement, the QMS can evolve and adapt, reflecting real-world challenges and needs across the digital health landscape.
Developers, researchers, and health tech startups interested in using or contributing to qmsOS can find more details in Tidepool’s latest blog post or by visiting the organization’s website.
About Tidepool
Tidepool is a nonprofit organization on a mission to empower the diabetes community through open-source, data-driven solutions. Its suite of tools enables people with diabetes, their caregivers, and healthcare providers to access and interpret diabetes data for better treatment decisions. By promoting transparency, interoperability, and innovation, Tidepool is helping to reshape the future of diabetes technology—and now, digital health regulation as well.
