Onera Health announces that the quality management system of its legal manufacturing subsidiary, Onera B.V., has been certified to meet the requirements of MDR (EU) 2017/745 regulation (Annex IX, chapter I and III).. The Onera STS 2 system, which will be marketed as part of the Onera hPSG® solution, falls within the scope of the EU MDR certificate. This certification ensures continued access to the next generation of Onera sleep testing products for patients in Europe.
“This certification is the culmination of many hours of work from our very dedicated team. I greatly appreciate the efforts from the Onera team and the partnership with MDR inspectors and auditors that came together to make this achievement possible,” states Ruben de Francisco, Founder and CEO of Onera Health. “This certification will enable many patients throughout Europe to benefit from polysomnography testing in their home.”
Source: Onera Health
