Certification of Mass Spectrometry Systems for IVD

Bruker Daltonics 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, believes that this is an important step forward for the further growth of the business. The ISO 13485 certification now allows the company to further develop several of their clinical research platforms towards IVD-CE certification and reimbursement: the MALDI BioTyperâ„¢ mass spectrometry system is already being adopted in clinical microbiology, and anticipation is growing
for the MALDI Molecular Imagerâ„¢ solution for molecular histology.
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.