Consistent quality assurance in the production and all processes in the company is our central aim and responsibility. As producer of medical products we understand our responsibility for the user of our products. Our production facilities are all certified to DIN ISO 13485:2016.
"The consistent adherence to product specification and the uncompromising application of quality management systems are central to our daily work."
Your point of contact for Quality management:
Quality Management Representative
- 9 64
78 - 43
Quality Certificates MEDINORM:
Quality Management System accordung to DIN EN ISO 13485:2016 - "Medical devices - Quality management systems - Requirements for regulatory purposes"
Certificate download: MEDINORM Certificate DIN EN ISO 13485:2016
Production Quality Assurance System Approval Annex V of the Directive on Medical Devices
Certificate download: MEDINORM Certificate - Annex V