Certifications

Qualimed and Desìo brand has received important quality certifications.

EN ISO 9001:2015

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 13485:2016

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 EN ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.

CE mark for contact lenses and solutions

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 510k

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.

▪ SDFA Saudi Arabia – Food and Drug Authority

▪ CAPA Approval

▪ Egypt Medical Advice Registration

▪ Medical Device Registration in the UAE

▪ AMAR- Medical Device Registration and Approval in Isreae

▪ DMP Approval – Marocco Medial device registration

▪ ANMAT  – The National Administration of Drugs, Foods and Medical Devices in Argentina

Free sales certificate issued by Italian Ministry of Health.

Local certifications in other foreign countries were obtained.