The international standard UNI EN ISO 13485: 2004 covers the medical device industry and specifies requirements for quality management systems that enable an organization to demonstrate its ability to provide medical devices and related services that meet the requirements of customer and applicable regulatory requirements.
In 2002 the Betatex SpA took this certification to ensure its customers a system of quality management more and more updated and efficient.

The Management System for Quality of Betatex SpA is certified according to UNI EN ISO 9001: 2008 . This standard defines the requirements for the development, in a company, of a system of quality management, in order to conduct business processes to improve the effectiveness and efficiency in the realization of the product and in providing the service .
The Betatex SpA took quality certification in 1994 with the aim to achieve and increase customer satisfaction.
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