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Clearbridge BioMedics achieves ISO 13485 certification and launches ClearCell™ System for cancer research markets

26 March 2012

 

Clearbridge BioMedics has achieved ISO13485 certification for the development of cell-based in-vitro diagnostic devices and today launched its revolutionary ClearCell™ System, for the cancer research market. This is one of the world’s first commercially-available systems that can successfully isolate circulating tumour cells (CTC) from blood, using biomechanical properties. The ClearCell™ System will be on showcase at the American Association for Cancer Research (AACR) annual meeting, from 31 March to 4 April 2012 in Chicago.

ISO 13485 is a comprehensive management system for the design and manufacture of medical devices. This certification has become the model standard for the medical devices industry and Clearbridge BioMedics is one of the few companies, within the CTC sector, to have met this Quality Management System. By complying with this regulatory requirement, Clearbridge BioMedics demonstrates its commitment to rigorous product development standards.

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