To ensure their quality standards, Medentis Medical GmbH carries out regular quality checks.
These include, for example:
- Surface chemical residue testing using X-ray photoelectron spectroscopy (XPS) to ensure high surface purity
- Routine bioburden determination and validation of bacterial count according to DIN EN ISO 11737-1 for the microbiological detection of organic purity
- Determination of breaking 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 the USP and FDA guidelines
- Cytotoxicity test of the materials used to demonstrate the biocompatibility in the quantitative growth inhibition test according to EN ISO 10993-5
- Continuous verification of manufacturing tolerances
- Regular checks of our suppliers
- Constant exchange in quality circles with university facilities for direct user feedback
These regular quality controls are defined in a device testing plan. The plan is to systematically test all products and product combinations at regular intervals.
Additional unscheduled quality controls are carried out as soon as essential processes such as packaging or acceptance of goods change or new suppliers are added. Of course, the tests and controls are carried out exclusively by external and neutral, accredited test laboratories.
ISO 9001 Certificate (English) (89,9 KB)
ISO 13485 Certificate (English) (93,8 KB)
CE-Certificate (English) (136,4 KB)
Studies, test results and research material of ICX-Implants can be found from Material bank.