Quality does not compromise.

In 1998 the company obtained certification according to UNI EN ISO 9001and UNI CEI EN ISO 13485 standards for its Quality Management System . Also in the same year with the entry into force of Directive 93/42 EEC all medical devices of its own production came into possession of the CE marking. In 2018 it obtained certification for the MDSAP (Medical Device Single Audit Program) System.

It is currently certified for the Quality Management System in accordance with UNI CEI EN ISO 13485:2021 and for MDSAP ISO 13485:2016 based on the applicable regulatory requirements on medical devices defined by the authorities of the countries Canada, Brazil and U.S.A for the activities: "Design, production of: acrylic teeth, PMMA discs, monomers and polymers for bridges and crowns and dental technology, dental impression materials.

The CE Certificate in accordance with Directive 93/42 EEC, and subsequent amendment Directive 2007/47/EC, currently in force was issued by the Kiwa Cermet Italia Notified Body.

Biocompatibility Statement - IT Disks