ISO 13485 is an internationally recognized quality standard specific to the medical device industry that ensures the quality and regulatory requirements throughout every step of a product’s life cycle.

It is a team effort and shows the dedication of every member of our company to aim for the highest quality – every day and in every step of our work.” Ruben de Francisco, Founder, CTO & interim CEO, explained, “Our team is proud to be awarded this certification, which illustrates Onera’s ongoing commitment to innovation and a comprehensive quality management system. This ISO certificate indicates that Onera meets or exceeds the stringent quality standards required in the medical device industry. Eindhoven – Ap– Onera Health, a leader in sleep diagnostic and monitoring solutions, announced today that its wholly-owned subsidiary in the Netherlands, Onera B.V., has been awarded the ISO 13485:2016 certification for Medical Device and Quality Management Systems from SGS (the world's leading inspection, verification, testing and certification company.