Processing validation

The existence of a valid processing validation is also mandatory for class I instruments latest as a result of the MDR. We already take into account the current requirements of the document RDS 007 actualized again in 2020 by the ZLG and of ISO 17664 3nd edition, as well as of course of the FDA Reprocessing guidance.

In addition, we perform testing of the non-detraction of the biocompatibility by repeated processing already for many years (according to fundamental requirement no. 6 of the MDR (as before: fundamental requirement no. 4 of the MDD), RDS 007 as well as of the recent standards and guidelines on biocompatibility).