Clearbridge BioMedics achieves ISO 13485 certification
Clearbridge BioMedics has achieved ISO 13485 certification for the development of cell-based in-vitro diagnostic devices and launched its ClearCell System, for the cancer research market.
“Through our ClearCell™ System, we are now entering the diverse and growing cancer research market. This in turn will have an impact on improving new therapies for cancer patients. We are targeting cancer research organisations and hospitals, which regularly need to isolate and analyse CTCs. We believe that ClearCell™ will be of particular interest to the research community, since it can retrieve viable and intact cells. Moving forward, we are working towards the development of the ClearCell™ System for in-vitro diagnostic applications,” said Johnson Chen, Co-Founder Clearbridge BioMedics.
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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