Flow Cytometry Manufacturing

Blue Ocean Biomedical has obtained ISO 13485: 2003 Certification for medical device manufacturing. In addition to certification for product design and development, this certifies that the company also complies with the 13485 standard for the manufacturing, distribution and service of flow cytometry systems.

As Blue Ocean commercializes the worlds first load & go? flow cytometer, this certification is a significant milestone in our overall strategy, said Ernie Thomas, president. In our global marketplace, quality standards for medical devices are getting stricter and at the same time more diverse. The 13485 certification provides a framework for meeting both customer and local regulatory requirements throughout the world.

About Blue Ocean Biomedical
Blue Ocean Biomedical, an ISO 13485 certified and privately-held company based in Pembroke Pines, FL, specializes in the development and manufacture of automated load & go? cell analysis systems for immune monitoring and related applications (http://www.blueoceanbio.com). Blue Ocean systems are optimized to address the needs for moderate-to-high-demand applications where test results are desired in less time, with greater efficiency and at substantially lower costs. The companys patented new CR Series Automated Cytometry Systems combine automated sample preparation and analysis in one integrated system that is Simple, Smart, and Efficient.