With regard to recognition, certificate and scope of application issued to GBA Medical Device Services GmbH is already available.

Effective March 1st, 2023, Dr. Timo Lebold and Felix Bunde have been appointed to the management of GBA Medical Device Services GmbH. By this, long-term experience in the medical device industry is combined with experience in business administration, strategic development, controlling, and project management.

Dr. Lebold and Mr. Bunde will further support the growth of GBA Medical Device Services GmbH to enable continuing of providing the high-quality service that defines MDS.

In terms of the daily business operations, nothing has changed for you. Test reports as well as other official documents will be updated successively. There is no need to adapt the contracts.

With regard to GLP certification, a certificate issued to GBA Medical Device Services GmbH is already available

A reproducible product cleanliness is an important prerequisite especially for biocompatibility and safe application of medical devices. This is not only valid for medical devices delivered sterile. Significant aspects of cleanliness (e.g. chemical production remnants) must also be taken into account in the case of instruments and other medical devices delivered non-sterile and intended for processing before use. For this and dependent on risk assessment and intended use, according to DIN TS 5343 (and ISO 19227) bioburden determination, endotoxin and particle test as well as cytotoxicity test and chemical analysis (organic, inorganic) are required.

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.