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 13485:2016-08 No. 109858M8
Certificate_13485-2016-08_109858M8.pdf
Adobe Acrobat Document 324.5 KB
Download
93/42 EEC Certificate No. 109859N2
Annex II excluding section 4 (Class Im Devices)
Certificate_93-42 EWG_109859N2.pdf
Adobe Acrobat Document 449.2 KB