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New findings – updated requirements?

Intelligent strategies undergo continuous development. We ensure our laboratories are equipped with the necessary testing systems to fulfil the requirements.

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 new document RDS 007 of the ZLG and of ISO 17664 2nd 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. 4 of the MDD, meanwhile also requirement of MDR, RDS 007 as well as of the recent standards and guidelines on biocompatibility).

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We are happy to provide information for specific products: