It is the international standard determining the special requirements for the companies, operate in the medical device manufacturing industry (diagnostic and therapeutic products).

The ISO 13485 Certificate ensures the continuity of the ability to determine and meet the customer demands for each company operating in the operational processes such as production, sale and procurement of medical devices.

It ensure the customer confidence on the fact that the products are manufactured in a system that is safe for human health in all phases such as beginning from raw materials to design, production, storing and shipment.

The ISO 13485 Certificate is required for manufacturers of medical devices to meet the legal requirements and to obtain CE Mark.