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Quality Management

To ensure our high quality standards, we carry out regular quality controls.

These include, for example:

  • Testing of chemical surface residues using X-ray photoelectron spectroscopy (XPS) to ensure high surface purity
  • Routine bioburden determination and validation of the bacterial count according to DIN EN ISO 11737-1 for microbiological detection of organic purity
  • Determination of breaking strength and fatigue strength according to DIN EN ISO 14801
  • Highly sensitive laboratory tests for the detection of superficial endotoxins according to the European Pharmacopoeia (Ph. Eur.) and in accordance with USP and FDA guidelines.
  • Cytotoxicity testing of the materials used to demonstrate biological compatibility in the quantitative growth inhibition test according to EN ISO 10993-5
  • continuous checking of the production tolerances
  • regular controls of our suppliers
  • constant exchange in quality circles with university institutions for direct user feedback

These regular quality controls are defined in a device testing plan. This plan provides for systematic testing of all products and product combinations at regular intervals.

Additional unscheduled quality controls are carried out as soon as essential processes such as packaging or goods receipt change or, for example, new suppliers are included.   Of course, the tests and inspections are carried out exclusively by external and neutral, accredited testing laboratories.

Current TÜV certificates:

701 KB)" rel="nofollow" class="ddownload-link id-3144 ext-pdf">ISO 13485 Certificate (701 KB) 5 MB)" rel="nofollow" class="ddownload-link id-3143 ext-pdf">CE-Certificate (5 MB)