Bruker Daltonik GmbH Receives ISO 13485 Certification for Development, Manufacturing and Distribution of Mass Spectrometry Syste
April 18 2008 - 6:00AM
Business Wire
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. ABOUT BRUKER CORPORATION (NASDAQ: BRKR)
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 www.bruker.com
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