ISO Certifications and Declarations of Conformity

DENTAL MARKET S.r.l. applies the standard European regulations regarding the design and the manufacturing of dental articles; moreover the excellence of our disposable leading articles is guaranteed following the specific certifications.

ISO 13485. Quality Management System for Medical Devices

ISO 13485 is a quality management system specific for manufacturing companies specialised in the production of medical products, which includes some aspects of ISO 9001 and specific requisites for the sector of medical devices. The certification ISO 13485 is an evidence of the continuous engagement of the company in the planning, in the manufacturing and in the commercialization of its products, following both the legislative requisites of the regulation and of market. This is an important point to understand the value of reliability for the Organizations in the medical field.

The Medical Devices in our products range are provided with technical files and declarations of conformity, duly registered in the Record of Italian Ministry of Health, according to the standard regulations and constantly updated considering the new European law on medical devices with deadline in 2020.

All of our certifications are annually renewed with the collaboration of KIWA CERMET.

To download all of our certifications, please CLICK HERE