Quality Management System Documentation

This page describes BUSCH & CO.'s quality management system covering development, manufacturing and/or distribution of rotating steel, carbide, diamond and ceramic instruments, rotating ceramic grinding bodies, polishing and brushes, and accessories for medical and non-medical purposes. The system is aligned with the international standard Medical Devices - Quality Management Systems - Requirements for regulatory purposes DIN EN ISO-13485:2016. For medical devices placed on the market in the European Union, the company fulfills the requirements of the Complete Quality Assurance System module according to Annex II of Medical Devices Directive 93/42EWG (with exception of section 4). The company has acquired competence to affix the CE mark on its medical devices after conducting the prescribed conformity assessment procedures. Ongoing performance is verified and certified through annual audits by an officially accredited Notified Body in Germany.