NovaQTech Insights
Oura Earns ISO 13485 Certification for Medical Device Software
On 7 October 2026, Ōura announced that its quality management system for medical device software has been certified to ISO 13485, the international standard for quality management in medical devices. 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.
Importantly, the scope does not cover Oura Ring hardware or the company’s general wellness features — and certification alone does not constitute regulatory clearance for any product. Oura cited its CE-marked Fertile Window feature, regulated as a Class I device in the EU, as an example of where the certified QMS applies.
The move signals the wearable maker’s strategic shift from consumer wellness toward clinical research and regulated digital health.
Source: Oura — https://resources.ouraring.com/oura-iso-13485-certification