Materials used for medical devices must be comprehensively characterized. Characterization includes knowledge of materials used, auxiliary and operating materials, and changes in the production process.
High requirements are placed on materials used in medical devices. For example, according to the MDR, they may only contain cmr substances in a concentration above 0.1 percent by mass if there is a special justification for the presence of these substances. One such substance is cobalt, which occurs both in CoCr alloys and as an impurity in stainless steels or other metals. In addition, we offer analytical testing services to characterize your materials.