Compliance with legal regulations and standards is a matter of course for us and an essential component of our corporate success.
ENDODOCTOR GmbH maintains a certified quality management system in accordance with the DIN EN ISO 13485:2016 standard, which defines the official requirements for a comprehensive quality management system in the manufacture of medical products. In addition, we meet the requirements of the EC Directive 93/42/EEC for medical devices and other national and international guidelines.
Certification according to 13485:2016 in particular places high demands on exact compliance with all process steps. Particular attention is paid to consistent and complete documentation and risk management. This internationally recognised standard for the quality management system of medical devices has been amended and its requirements significantly increased. It is not only about risk minimization, but also about complete traceability of products and parts.
With the certification according to DIN EN ISO 13485, we not only want to prove the safety of our medical products, but also actively communicate the quality standards of our company to the outside world.