Tidepool Earns ISO 13485 Certification for Open-Source Quality Management System, Paving Way for SaMD Innovation

Tidepool Achieves ISO 13485 Certification for Open-Source Quality Management System PALO ALTO, Calif.--(BUSINESS WIRE)--Tidepool, a nonprofit organization committed to empowering the diabetes community through open-source innovation, is pleased to announce that it has received ISO 13485:2016 certification for its open-source Quality Management System (QMS), known as qmsOS. This achievement, awarded by TÜV SÜD America, highlights Tidepool’s dedication to maintaining the highest standards of quality and safety while promoting transparency and accessibility in the medical device industry. Traditionally, QMS frameworks have been proprietary, creating substantial barriers for smaller organizations and startups trying to enter the regulated medical device market. Tidepool’s qmsOS aims to change this by offering a collaborative, adaptable system that aligns with modern software development practices and meets regulatory requirements. "Our mission has always been to break down barriers—whether in diabetes technology, regulatory transparency, or industry collaboration," stated Jake Nardone, Tidepool’s Head of Quality and Regulatory Affairs. "Achieving ISO 13485 certification for an open-source QMS is a significant milestone. With qmsOS, we are demonstrating that regulatory compliance can be both stringent and accessible, thereby enabling more innovators to bring life-changing solutions to market more quickly." ### Lowering Barriers to Regulatory Compliance For emerging digital health companies, navigating regulatory requirements can be daunting. Tidepool’s qmsOS simplifies this process by providing a structured, compliant framework built on widely used tools such as Google Workspaces, Atlassian (Jira and Confluence), and Slack. Designed with agile development in mind, qmsOS ensures that developers can integrate regulatory best practices seamlessly into their workflows without compromising innovation. "Regulatory complexity should not impede innovation," emphasized Howard Look, Founder of Tidepool. "By making our QMS open source and now ISO 13485 certified, we are offering a resource that can help other companies accelerate their development of Software as a Medical Device (SaMD) while ensuring compliance with international standards." ### A New Era of Open-Source Medical Device Development ISO 13485 is the globally recognized standard for quality management systems in the design and manufacture of medical devices. By earning this certification for an open-source QMS, Tidepool is leading a shift in the industry towards greater transparency, collaboration, and knowledge sharing. In line with its commitment to fostering industry-wide innovation, Tidepool encourages digital health developers, startups, and researchers to explore, contribute to, and adopt qmsOS in their regulated software development processes. For more information about Tidepool’s open-source QMS and its potential to support SaMD development, visit the latest blog post on their website. ### About Tidepool Tidepool is a nonprofit organization focused on creating open-source software to unlock diabetes data, providing valuable tools for people with diabetes, caregivers, and healthcare providers to make more informed treatment decisions. By promoting a culture of transparency and collaboration, Tidepool is redefining the future of diabetes technology and digital health innovation. For more details, visit tidepool.org. Follow Tidepool on Twitter at @Tidepool_org and on Facebook and Instagram.