NEW: MEDI-GEHR

After decades of experience as a supplier to the medical industry for the production of blood suction tubes, medical drains, etc., it was a logical step to expand our range with the MEDI-GEHR® product line to include semi-finished products that meet the special quality and safety standards in the medical technology sector. For this purpose, our company headquarters in Mannheim and the US production site in Philadelphia were certified in 2016 and 2018 according to the requirements of a Medical Devices Quality Management System according to quality standard ISO 13485 for the production of semi-finished products. All MEDI-GEHR® products are suitable for medical and pharmaceutical applications with direct body contact with tissue, bone, skin and mucous membrane up to 24 hours.

OUR CERTIFICATIONS
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. At both production sites we are producing following semifinished products:

• MEDI-GEHR PEEK MG®
• MEDI-GEHR PPSU MG®
• MEDI-GEHR PP MG HT®
• MEDI-FIL-A-GEHR PEEK MG®.

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

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.

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

More information: https://en.gehr.de/products/medi-gehr/