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.

Preview Certificate ISO 13485
Certificate ISO 13485
PDF, Pages: 1
~661 KB
Preview Certificate annex II
Certificate annex II
PDF, Pages: 1
~591 KB
Preview Certificate annex V
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.
Acrobat Reader Download

Raguse - certificated quality

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