Quality & Laboratory
MALDI-TOF
Laboratory
XDG‘s laboratory is accredited by the Dutch Accreditation Council (RvA) according to EN ISO/IEC 17025:2015 (RvA registration number: RvA-L 614). The laboratory tests our products’ conformity with microbiological, physical and chemical performance requirements defined by the relevant standards (such as EN ISO 11133 or GMP) or – if required – according to customer specific test protocols. Furthermore the laboratory offers myXDG Confirmation Services with MALDI-TOF MS technology and assists our customers with validation and verification work related to the implementation of our culture media.
Quality
EN ISO 9001 & IVDR
- XDG has a multi-site certification according to EN ISO 9001; Many of our products are CE-marked (IVDR complient).
- Our products are compliant with
IVDR (Regulation (EU) 2017/746). - Our quality systems assure the consistently high quality of our products and the continuous improvement of our processes.
EN ISO 17025 & EN ISO 11133
- Our procedures to manufacture, store, transport and distribute our products comply with the requirements of ISO 11133 and follow the “Good Manufacturing Practice (GMP)”.
- Our products are quality controlled by our ISO 17025 accredited laboratory according to ISO 11133, GMP and all other relevant standards.
About us
Xebios Diagnostics Group (“XDG”) manufactures culture media for microbiological diagnostics, water and environmental analysis as well as for samples from the food & beverage, pharmaceutical and cosmetics sectors and for samples of clinical/veterinary origin at its three production sites in Düsseldorf, Eindhoven and Groningen.