To ensure that we meet our high quality standards, we conduct regular quality inspections. 

These include, for example:

• Analysis of chemical surface residues using X-ray photoelectron spectroscopy (XPS) to ensure high surface purity
• Routine bioburden testing and validation of microbial count determination in accordance with DIN EN ISO 11737-1 for the microbiological verification of organic purity
• Determination of Breaking Strength and Fatigue Strength in Accordance with DIN EN ISO 14801
• Highly sensitive laboratory tests for the detection of surface-bound endotoxins in accordance with the European Pharmacopoeia (Ph. Eur.) and in compliance with USP and FDA guidelines
• Cytotoxicity testing of the materials used to demonstrate biocompatibility in a quantitative growth inhibition test in accordance with EN ISO 10993-5
• Continuous monitoring of manufacturing tolerances
• Regular inspections of our suppliers
• Ongoing exchange in quality circles with academic institutions to gather direct user feedback

These regular quality controls are specified in a device testing plan. This plan calls for systematically testing all products and product combinations at regular intervals.

Additional unscheduled quality controls are conducted as soon as key processes—such as packaging or goods receipt—change, or when new suppliers are brought on board. Naturally, the tests and inspections are carried out exclusively by external, impartial, and accredited testing laboratories.