Certification strengthens Oura’s foundation for the next chapter of healthcare innovation, spanning wellness and regulated digital health.
SAN FRANCISCO–(BUSINESS WIRE)–ŌURA, a leading health intelligence platform and maker of the world’s smallest smart ring, today announced that its quality management system for medical device software has been certified to ISO 13485, the internationally recognized quality-management standard for medical devices. The certification covers the development, production, and distribution of medical device software used in digital health applications to monitor and analyze physiological data. It strengthens Oura’s positioning as the company expands its work across consumer wellness, clinical research, and regulated digital health.
ISO 13485 certification reflects the quality management system Oura has put in place to manage risk, support product safety, incorporate feedback, and improve its products over time. It also provides a strong base for Oura to develop medical device software and evaluate appropriate regulatory pathways in the United States and other markets.
“Trust in healthcare depends not only on what a digital health tool does, but on how it is designed, validated, monitored, and improved over time,” said Dr. Ricky Bloomfield, Oura’s chief medical officer. “ISO 13485 strengthens that foundation as Oura continues to support research and clinical applications while building toward more clinically meaningful uses of continuous health data.”
Supporting Oura’s growing role in healthcare
Oura’s mission is to empower people to live healthier, longer. That starts with helping people understand their health every day, while building toward a broader role in healthcare. The company recently completed a large-scale blood pressure study through Oura Labs, exploring whether Oura data might inform future blood pressure features, subject to appropriate regulatory review. ISO 13485 certification is an important step along that path, giving the company a stronger platform for future healthcare work and reinforcing its commitment to earning trust with members and partners. Because certification requires ongoing review, it represents a long-term commitment, not a one-time milestone.
What the certification means
The certification covers the design, development, manufacturing, and distribution of medical device software for digital health applications that monitor and analyze vital and non-vital physiological parameters. This includes Oura’s Fertile Window feature, a software as a medical device (SaMD) feature classified as a Class I device in the European Union and CE marked for use there. This certification is one of several steps in Oura’s expansion into clinical research and health systems, reflecting its investment in the quality systems needed to support work in these settings. It does not apply to any specific Oura software, hardware, or general wellness features.
The certification does not, by itself, establish clinical safety and efficacy for a specific feature, constitute regulatory clearance or approval for every Oura feature or product, mean that future features will receive regulatory clearance or approval, or that Oura products replace professional clinical care.
Quality as a foundation for future innovation
As wearable companies add more clinically relevant features, quality and regulatory responsibility increasingly depend on the systems used to design, evaluate, monitor, and maintain those features over time, not simply on the presence of a medical feature within a broader consumer product. Oura’s ISO 13485 certification reflects a quality management system that brings those considerations into the product development lifecycle.
Oura believes the category should advance through a combination of innovation, evidence, quality controls, and appropriate regulatory oversight. At the same time, the company will keep building wellness features that help members understand and manage their health, while evaluating opportunities for future regulated digital health software. With ISO 13485 in place, Oura is better equipped to do that work alongside healthcare providers, researchers, and partners.
About Oura
Oura is a health intelligence platform designed to transform how people understand and manage their health in everyday life. Oura’s platform is anchored by Oura Ring, the world’s leading smart ring that empowers you to live healthier, longer. Oura supports millions of members worldwide across sleep, activity, stress, readiness, women’s health, metabolic health, and heart health. Oura Ring is purpose-built to leverage the finger’s unique physiological advantages for photoplethysmography (PPG) measurement, producing a stronger signal than wrist-based wearables. The core metrics of the lightweight Oura Ring are scientifically validated against gold standards and the ring tracks 50+ health metrics continuously, empowering both individuals and thousands of research teams, healthcare providers, sports teams, and organizations. Trusted by an ecosystem of more than 1,200 partners, Oura is advancing the future of preventative health with privacy and security at the forefront.
Founded in Finland in 2013, Oura is headquartered in San Francisco with E.U. headquarters in Oulu, Finland.
Except as otherwise stated for regulated features, Oura Ring is not a medical device and is not intended to diagnose, treat, cure, monitor, or prevent medical conditions or illnesses.
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