Our company headquarters in Mannheim and the US production site in Philadelphia are certified according to the requirements of a Medical Devices Quality Management System in accordance with quality standard ISO 13485 for semi-finished products. Any raw materials used for medical grade products are food compliant (FDA, EU 10/2011). All MEDI-GEHR® products are suitable for medical and pharmaceutical applications in direct body contact with tissue, bone, skin and mucous membrane up to 24 hours. They have been tested and evaluated by independent, accredited test laboratories and
meet the following biocompatibility requirements:

• ISO 10993-1: Evaluation and testing within a risk management process*
• ISO 10993-5: Tests for in vitro cytotoxicity
• ISO 10993-12: Sample preparation and reference materials*
• ISO 10993-18: Chemical characterization of materials*
• USP Class VI*

*on demand

In addition, we use ultrasound to check our semi-finished products during production for defects and voids. As a manufacturer, we thus comply with special due diligence requirements which facilitates medical device manufacturers to obtain approval for their final products by reducing
costs and time.

We also attach great value to the traceability of stock goods leaving our production facilities. We also follow the VDI guideline for “Medical-grade Plastics”. It goes without saying that we are certified according to the management systems ISO 9001 Quality, ISO 14001 Environment, ISO 50001
Energy and ISO 45001 Occupational Health and Safety.

We are particularly proud of the fact that, in addition to our stock shapes, we can also implement individual customer solutions.
Please contact us!