Quality and certification

Reliability and quality have always been characteristics that customers and professionals in the sector recognize with Qualimed, constantly committed to the development and improvement of its product. In fact, Qualimed has all the certifications that can attest the standard medical quality.

EN ISO 9001:2008

Is the internationally recognised standard for the quality management of businesses and applies to the processes that create and control the products and services an organisation supplies, prescribes systematic control of activities to ensure that the needs and expectations of customers are met.

EN ISO 13485:2003

Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

CE MARK

A mandatory conformity mark for products placed on the market in the European Economic Area (EEA). With the CE marking on a product, the manufacturer ensures that the product conforms with the essential requirements of the applicable EC directives.

FDA APPROVAL

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health. FDA certificate assures that a product meets US FDA requirements for medical devices sold in the USA.