Quality and certification

Reliability and high quality have always been distinctive traits of Qualimed, continually committed to developing and elevating its own production standards. Qualimed takes pride in possessing all certifications attesting to its rigorous quality standard in the medical device sector.

UNI EN ISO 9001:2015

This standard is the reference for cyclic quality control of the production process, starting from defining customer requirements and then monitoring the entire production path. Customer satisfaction is the focal point of ISO 9001.

UNI EN ISO 13485:2021

This standard sets requirements for a Quality Management System for medical devices, ensuring compliance with requirements at every stage of the product lifecycle, from design to market release.

CE MARKING

Mandatory for products subject to European directives, the CE mark is affixed by the manufacturer within the European Union, asserting the product’s conformity to safety requirements of applicable EU directives or regulations.

FDA 510K Clearance

Issued by the US government agency, FDA, which regulates food and pharmaceutical products, FDA 510k approval signifies compliance with stringent US standards for public health protection.

Qualimed is certified with all necessary national and local authorizations to meet the international market. We distribute our products under the Desio brand in Europe, Asia, Africa, Middle East, South, Central and North America. Strict adherence to essential safety and quality requirements, within the context of health and environmental protection, is our top priority.