In January 2021 a new standard, ISO 10993-23, covering tests for irritation was issued that prescribes the use of in vitro test methods before considering any in vivo tests, all to fulfil the 3R principle of replacement, reduction, and refinement of animal tests.

With the new certificate, the renaming to GBA Medical Device Services GmbH was successfully completed with all relevant authorities.

A state-of-the-art LEAN-optimized laboratory is being built close to the current site, which will bring a fourfold increase in capacity compared to the current laboratory space. The company, which is part of the GBA Group, relies on state-of-the-art digital processes to increase the efficiency of laboratory workflows and continue to optimally meet customer requirements for faster throughput times.

With ISO 10993-1:2018 and ISO 10993-18:2020 the importance of material characterization by chemical analysis in the course of biological evaluation of medical devices has greatly increased.

The performance of the cytotoxicity test serves the medical device manufacturer to prove the biocompatibility of its product, e.g. in the context of a CE marking, and to identify biological hazards and to assess the risk of the product already during product development.