In the immediate neighbourhood of the almost 30-year-old GBA MDS headquarter, a state-of-the-art LEAN-optimized medical device testing laboratory has been developed over the last few months. With 2,700 m² of floor space, the laboratory area has quadrupled to over 1,600 m².

Maintaining the sterility assurance level (S.A.L.) achieved through sterilization by the sterile barrier system (SBS) is a fundamental objective of the DIN EN ISO 11607 series.

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 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.