Certificates

Aurum Medion is ISO 9001:2015 accredited in the disposable Medical Devices quality standard. ISO 9001 specifies the standards for our organization’s Quality Management System to Design, Manufacture, and Deliver medical devices that satisfy customer, statutory, and regulatory requirements. The standard also lays out a structure for evaluating customer perception and making changes.

Aurum Medion Technology is ISO 13485:2016 certified for disposable medical devices. We use competent and efficient quality management methods to assure consistent quality, product safety, and the long-term success of our products. As a result, you can assured that our product will fulfil all applicable regulatory standards across the world.

Aurum Medion is approved for disposable medical devices. The CE mark signifies that our product complies with EU health, safety, and environmental protection requirements. It means that the product may be sold freely in any region of the European Economic Area, regardless of where it was manufactured.