Company
Lambda GmbH is a 100% subsidiary of Greiner Bio-One GmbH.

Quality

Quality means the implementation of customer requirements, user-friendly products and, most importantly, utmost security for patients and users. To ensure all this, we rely on innovative, highly-qualified staff and an elaborate and effective quality management system. We meet a variety of internationally accepted quality standards.

1. Management system

 

2. Product Standards

  • IVDD 98/79/EC Directive 98/79/EC of the European Parliament and Council of 27th October 1998
    on in-vitro diagnostic medical devices
  • EN ISO 14971:2007 Medical devices – Application of risk management to medical devices
  • EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
  • EN 13640:2002 Stability testing of in vitro diagnostic reagents
  • EN 375:2001 Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
  • EN 980:1996 Graphical symbols for use in the labelling of medical devices

  • EN ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes