QUALITY AND REGULATORY

INNOVATION, ATTENTION TO DETAIL AND PATENTED DESIGNS IS A MIRROR OF EXCELLENCE.

 

We believe that care in design, research, attention to detail, high-quality raw materials and rigorous manufacturing processes are the basis of a reliable, high-performance product.

Nowadays, having a quality certificate is essential  he stringent quality standards required and to satisfy the highest expectations. For this reason, quality production means for us using guaranteed and certified materials, being detail-oriented and guaranteeing 100% Made in Italy products.

ADVAN’s quality certificates perfectly reflect our dedication to the safety and reliability of all our products and services at all stages of design, development, production and distribution of our dental implants.

We are a certified company according to the international standard EN ISO 13485:2016, and we operate in  accordance with Legislative Decree No. 46 of 24 February 1997 (implementation of EU MDD No. 93/42/EEC) and Regulation 745/2017.

 

QUALITY

STRUCTURES, DIMENSIONAL CONTROLS AND SELECTED MATERIALS TO ENSURE SAFETY AND QUALITY PERFORMANCE.

The quality of Advan’s plants, and of all its components, is guaranteed by a production entirely Made in Italy: every phase of engineering, development, processing, creation of the patented design, choice of implant surface, production and packaging, are subjected to the most rigorous controls through fully automated inspections supervised by highly qualified company personnel.

Our passion and meticulous research of quality are reflected in all our products and their processing to guarantee a consistently high-quality standards.

 

CERTIFICATIONS

The notified body for product conformity assessment is TÜV SÜD P.S. GmbH. We hold a quality management system certification in the medical field: this means that our products and services are compliant with current laws and regulations, thanks to the adoption of tested, controlled and constantly improved organisational models.

All medical devices, placed on the market, bear the CE marking: this proves that our products meet all requirements foreseen by Directive 93/42/EEC regarding, for example, safety, choice of materials and biocompatibility.

The company boasts also a significant experience in product registration in extra-European markets. This procedure might often be particularly time-consuming and must be completed before medical devices such as dental implants are released onto the market.

EN ISO 13485:2016 certificate

CE Certificate and confirmation letter

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