Certification

Our understanding of quality goes beyond the quality of the product itself and incorporates all aspects of the company performance. For us, quality is a comprehensive strategic success factor for achieving the company goals.

To implement our quality policy relating to the manufacturing of medical devices, our company introduced and maintains a process-oriented quality management system in accordance with DIN EN ISO 13485. In addition to this, we are committed to meeting the requirements of the Medical Device Directive 93/42/EEC and proving conformity.

Download
Certificate EN ISO 13485:2012 + AC:2012
13485 Certificate No. 51280-11-03 _ E.PD
Adobe Acrobat Document 2.2 MB