Quality management
Our introduction of a quality management system in 1998 was a great success. As a producer of medical products we are subject to strict laws such as the German 'Medizinproduktegesetz' MPG and the guideline 93/42/EEC
As a result of continual audits we have been able to prove that our quality management system satisfies all requirements. These requirements are:
- DIN EN ISO 13485
- Annex II of the guideline 93/42/EEC
- Annex V of the guideline 93/42/EEC
Certificate Download
You can view our certificates by using the following links, in PDF format.
![]() Certificate ISO 13485 PDF, Pages: 1 ~661 KB | ![]() Certificate annex II PDF, Pages: 1 ~591 KB | ![]() Certificate annex V PDF, Pages: 1 ~551 KB |
Instruction for use
To view the PDF files, you need the Acrobat Reader from Adobe, you can download a recent version of Acrobat Reader for free by using the following link.









