After decades of experience as a supplier for the medical industry, it was a logical step to reach out to new customer groups with the certification according to the Medical Devices Quality Management System Standard ISO 13485. Our company headquarters in Mannheim and the US production site in Philadelphia were certified in accordance with the requirements of the ISO 13485 quality standard for semi-finished products in December 2018.
In addition to the already achieved process stability, we continue to work on various product certifications according to ISO 10993.
With the already implemented management systems ISO 9001 Quality, ISO 14001 Environment, ISO 50001 Energy, OHSAS 18001 Occupational Health and Safety and now with the medical certification, we belong to a circle of highly qualified companies that are able to supply this demanding industry.
ISO 13485 is regarded as the worldwide standard for the manufacture and distribution of medical devices. It essentially refers to the specific requirements for product safety, detailed documentation and proof of compliance, as well as the establishment of a risk management system.
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