We are continually optimizing our ISO 9001:2008 quality management system, which has been certified since 1992. And the response from our customers has been overwhelmingly positive: Almost all of them gave our services and the management system the highest possible ranking.
Food contact and regulations
Due to various product formulations it is not possible to make any general statements in regards to food contact regulations. For further information, please contact the listed contact person.
For medical applications, the European approval procedure is laid out in Directive 93/42/EEC. The national implementation of this directive into German law is the Medizinproduktegesetz (Medical Products Act) of August 1994. The detailed procedure to be followed is described in the pertinent international and national standards (e.g., ISO 10993, DIN EN 30993-1).
The DAB monographs (German Pharmacopoeia, current edition) or those of the European Pharmacopoeia (current edition 2008) can be used as supplementary regulatory works to make the decision in special cases.
Manufacturers of medical device applications are responsible for submitting their coated parts to the relevant test conditions for their end use requirements. Our staff can provide product related information based on experiences with the various approval processes.