GBA Medical Device Services was founded in Gilching near Munich in 1994 and is one of the leading providers for the qualification and evaluation of medical devices in Europe.

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 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.