Any characteristic, feature or condition of a person or of a thing needed to define its nature and distinguish them from others.
That is the general definition and in our company the Quality Assurance System includes all related and interconnected activities that influence the Quality of products and services. The system ensures that all our instruments, bought by anyone anywhere at any time in the past, present or future, do and always will comply with the sector international regulations. This warranty is periodically checked and certified by world recognised independent certifying bodies. Currently, our quality is certified to comply with UNI EN ISO 13485:2012 – Medical devices Quality Systems by TŰV SUD – Italy both for devices Class 1, and Class 2. All our instruments feature a lasered lot number that grants full traceability for each one of them. As European manufacturer we also must feature the CE marking on all our products. It certifies the conformity of production processes to Italian and EU safety regulations for Medical Equipment. We also have the Certificate of Free Sale issued by the Italian Ministry of Health, valid for exports outside the European Union, certifying CE conformity.
Registrations in Foreign Countries
To be able to sell outside the European Union, it is necessary to register the company and the products with the local Ministry of Health. These actions are taken by single states to regulate the import of Medical Equipment in order to protect the health and safety of their citizens. Here some of our registrations: China – Saudi Arabia – Ukraine – FDA U.S.A.
