The quality management system adopted by Titanmed is compliant with UNI EN ISO 13485:2016 regulations.
The components produced by Titanmed have technical characteristics compliant with EEC directive 42/93 and as amended and supplemented.
Titanmed assists the customer also handling the entry procedure of the components produced in its Technical Dossier in order to obtain EEC type-examination.
In the cases in which the customer wishes to obtain its own complete certification or OBL (Own Brand Labelling) contract, from a standpoint of comprehensive service, the Titanmed Quality Office works together with the customer's consultants to provide additional information and services needed to complete the filing procedure.
Indeed, in order to guarantee analytical control and certification of the sterilisation and treatment of the materials, Titanmed may provide laboratory services through its scientific partners, like microbiological analysis, chemical analysis, material strength analysis, dosimetry analysis, radiometric measurements, product sterility analysis, check for contamination of raw materials, dosimetry on irradiated materials, mechanical and material strengths, validation of sterilisation processes and validation of wrapping systems.