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.

The company is currently certified for its Quality Management System in accordance with the UNI CEI EN ISO 13485:2021 standard and for MDSAP ISO 13485:2016 based on the regulatory requirements applicable to medical devices as defined by the authorities in Canada, Brazil, and the U.S. for the following activities: Design and manufacture of: acrylic teeth, PMMA discs, monomers and polymers for bridges and crowns and dental technology, dental impression materials, and distribution of dental devices.

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