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

23 Apr 2008 - Bruker Daltonics announced 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(tm) mass spectrometry system is already being adopted in clinical microbiology, and we are also very excited about our MALDI Molecular Imager(tm) 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."