Bruker Daltonik GmbH Receives ISO 13485 Certification for Development, Manufacturing and Distribution of Mass Spectrometry Systems for IVD

BARCELONA, Spain–Before the 18th European Congress of Clinical Microbiology and Infectious Disease (ECCMID) opening here tomorrow, Bruker Daltonics announces that it has received EN ISO 13485 certification for its German operations. This ISO 13485 certification is an important milestone in the development of the Bruker Daltonics in vitro diagnostics (IVD) business, particularly in the fields of clinical proteomics, clinical microbiology and molecular imaging in pathology.

Dr. Wolfgang Pusch, Assistant Vice President of the Bruker Daltonics Clinical Research Systems business, commented: “This is an important step forward for the further growth of our business. Our ISO 13485 certification now allows us to further develop several of our clinical research platforms towards IVD-CE certification and reimbursement: our MALDI BioTyper™ mass spectrometry system is already being adopted in clinical microbiology, and we are also very excited about our MALDI Molecular Imager™ solution for molecular histology. Moreover, many of our customers are accelerating their peptide and protein biomarker discovery and validation efforts, and we expect the emergence of future IVD multimarker panels for clinical proteomics.”

Dr. Ulrich Weller, the Head of Microbiology at the Center for Laboratory Medicine and Hemostaseology at the Dr. med. Christiane Boogen clinical laboratory in Cologne, Germany, pointed out: “We have just recently introduced the Bruker MALDI BioTyper system in our clinical microbiology routine analysis. The market is certainly ready for such a next generation microbial identification approach. I see with great interest that Bruker Daltonics is committed to support the community of routine laboratories in microbiology and laboratory medicine with the necessary ISO 13485 quality management.”

About the Bruker MALDI BioTyper™

Bruker’s dedicated research-only MALDI BioTyper solution enables identification, taxonomical classification or dereplication of microorganisms like bacteria, yeasts and fungi. Classification and identification of microorganisms is achieved reliably and fast using high-throughput MALDI-TOF mass spectrometry. Applications exist in clinical research, environmental and taxonomical research, as well as in food processing and in quality control. Bruker’s robust method requires minimal sample preparation efforts and has very low costs per sample.


Bruker Corporation has recently become the parent company of the entire Bruker group of companies. Bruker Corporation now operates in two segments, the Life Science and Analytical (LSA) systems segment, and the Advanced Supercon segment. For more information, please visit

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