EUROIMMUN AG is a leading manufacturer of reagents for laboratory medicine. It focuses on test systems for the identification of concourse antibodies in patients’ serums, which facilitate diagnosis of autoimmune and infectious diseases as well as allergies. The widespread use of EUROIMMUN’s products is evidence of their quality and reliability: More than 3000 laboratories across the world use EUROMIMMUN’s products. An example of EUROIMMUN’s innovative power is the BIOCHIP: a coating of cells or tissue sections is applied to paper-thin cover glasses, automatically cut to millimeter-sized fragments, and glued onto microscope slides.

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EUROIMMUN AG implements standards for development processes – with in-STEP BLUE

Using in-STEP BLUE allows EUROMIMMUN AG to standardize and document technical development processes. This includes adhering to legal provisions for the development of medical devices. For example, DIN 62304 prescribes a risk analysis for each requirement, which in turn leads to risk control measures requiring their own risk analyses. This process, which continues until residual risks are reduced to a minimum, is mapped by in-STEP BLUE. in-STEP BLUE provides most of the required documents based on templates and data sets:

  • Development plan
  • Requirements specification
  • Architecture
  • Risk management dossier
  • Configuration management
  • Functionality dossier
  • Approval