QUALITY

In a sector characterized by high standards and competitiveness, being able to offer high quality products has been the fundamental aspiration of Bioner since its inception. This is the reason why the company carries out its activities in accordance with international regulations that ensure the highest quality of the outcome.

QUALITY

BIONER complies with all Quality standards applicable to the Medical Device sector.

The company Quality management system is based on the ISO 13485:2016 standard “Medical devices. Quality management systems”, and it is periodically audited by an authorised notified body.

This , along with the maintenance of the License granted by the Spanish Agency for Medicines and Health Products (AEMPS), guarantee that BIONER products are manufactured, controlled and marketed, complying with the quality standards of the sector.

Currently, BIONER complies with the new Regulation (EU) 2017/745, entered into force on May 2021, having obtained the CE certificate through the notified body CE0051 (IMQ). This fact positions Bioner at the highest level among companies in the dental sector.

Instructions for use

Read the instructions for use of any of the product families that form the Bioner catalog in order to obtain detailed information on its operation and the precautions that must be taken into account during its use. These instructions for use are designed to support professionals in the field of Dentistry.