Onera obtained ISO 13485 certification

Onera B.V. has achieved the ISO 13485:2016 certification for its quality management system. This certification demonstrates compliance with the international standard that specifies the requirements for medical devices and related services.

Onera obtained ISO 13485 certification

Eindhoven – April 8, 2021  –  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. This ISO certificate indicates that Onera meets or exceeds the stringent quality standards required in the medical device industry.

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. 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.”

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. To receive certification, organizations must demonstrate that their Quality Management Systems deliver medical devices and related services that consistently meet customer and regulatory requirements, including design, development, quality assurance, quality management, product safety, customer service, and quality improvement.

“It was important to us to implement the requirements from the very beginning of our company, as we understand that safety and quality are non-negotiable in the medical devices industry. SGS Belgium (notified body 1639), an official certification company, has now given us the formal certification after a thorough audit process and we are very proud that our processes are fully compliant with the highest standards, which reflects the maturity of our company,” said Mr. de Francisco.

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world. For more information, please visit

About Onera Health

Onera Health is a leader in transforming sleep medicine and remote monitoring. Their breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. Onera is headquartered in California’s Silicon Valley and has R&D offices in the Netherlands. For more information, please visit


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