Quality management

Our quality management system encompasses the following areas:

Development, manufacture and/or sale of rotary steel, carbide and diamond instruments, rotary ceramic abrasives, polishers and brushes, as well as accessories for medical and non-medical use

and is based on the requirements specified by the international standard for quality management systems DIN EN ISO 9001:2008. 

In the case of medical devices, these specified requirements are fundamentally supplemented by the additional requirements of the international standard DIN EN ISO-13485:2003 + AC 2007.  

For medical devices placed on the market in the European Union, we also comply with the requirements of the module "Total quality assurance system" in accordance with Annex II, section 3 of Directive 93/42/EEC and Directive 2007/47/EC as from 21.3.2010 onwards.

Certificate (303KB)

On completion of the conformity assessment procedure specified for the products, we are consequently entitled to feature the CE mark on our medical products.
Our continual efforts to maintain the quality system are verified through annual investigations (audits) by an officially accredited, notified body in Germany and certified when confirmed.

Our notified body (as stipulated by the EC Directive)
is accredited by the central health protection office
of the German Federal States for pharmaceuticals and medical devices (ZLG).
In addition, our selected notified body has the
competence conferred by the German Accreditation
Council to certify quality management systems in
 accordance with the standards DIN EN ISO 9001 and DIN EN ISO 13485.