Aurora Sterilisation achieves ISO 13485:2016 certification for its Quality Management System (AcT)

Aurora Sterilisation, designer and manufacturer of oxygen plasma sterilisers, announces that it has been awarded ISO 13485:2016 / EN ISO 13485:2016 certification by the Notified Body DNV Product Assurance AS (2460) on 23 October 2026⁽¹⁾. This international recognition confirms that its quality management system meets the specific requirements of the medical device sector.

A global benchmark

ISO 13485 is the global quality benchmark for medical device manufacturers. It covers the entire product life cycle, from design to servicing, with strong requirements for risk management and traceability. For Aurora Sterilisation, this certification is a key step towards bringing its solutions to market and further strengthening the trust of its hospital customers.

The certificate covers all of the company's activities: design, manufacture, sale, distribution, installation, servicing and refurbishment of plasma sterilisers, sterile barrier systems and accessories.

A mark of confidence for healthcare facilities

“This certification rewards the rigorous work of all our teams. It confirms that our Quality Management System meets the requirements of ISO 13485 and is a fundamental step towards CE marking of our devices,” said Florian Paupert, Director of Regulatory Affairs and Quality Assurance at Aurora Sterilisation.

For hospitals, clinics and distribution partners, the certification provides assurance of an independently audited quality system, from design through to after-sales service. It also supports the company's regulatory processes in Europe and internationally.

Press contact:

Aurora Sterilisation – 177, Boulevard de l'Yser - 76000 Rouen, France

Jan Laarman

E-mail: jan.laarman@aurora-sterilisation.com

Website: https://www.aurora-sterilisation.com

About Aurora Sterilisation

Aurora Sterilisation develops innovative sterilisation technology for medical devices, aiming to protect patients, support medical innovation and preserve the environment through a process that is safe for both health and the environment.

⁽¹⁾ ISO 13485 certification applies to Aurora's Quality Management System. It does not constitute CE marking. The AQSANIIT® steriliser is a Class IIa medical device currently undergoing conformity assessment by the Notified Body DNV (2460) under Regulation (EU) 2017/745. It does not yet bear the CE mark and may not be made available or sold until it has been obtained.