SAN DIEGO, CA--(Marketwire) - BioLegend in San Diego, CA, a leading provider of antibodies and reagents for biomedical research, has been granted ISO 9001:2008 certification for manufacturing and distribution of antibodies, proteins, and chemical reagents for research use, and ISO 13485:2003 certification for manufacture and distribution of antibodies, proteins, and chemical reagents for use in the medical device industry.
ISO 9001:2008 specifies international standards for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and regulatory requirements and its aim to enhance customer satisfaction, including processes for continual improvement.
ISO 13485:2003 certification is globally recognized for establishing a standardized quality management system for the design and manufacture of medical devices that meets both customer and regulatory requirements.
"BioLegend has reached a significant milestone in achieving ISO 9001:2008 and ISO 13485:2003 certification. This demonstrates our company-wide commitment to world-class quality to our customers and collaborators," said President and CEO, Gene Lay. "We strive to meet or exceed our customers' expectations every day, via scientific innovation, continuous improvement, and outstanding value."
BioLegend develops and manufactures world-class, cutting-edge antibodies and reagents at an outstanding value to customers for biomedical research. The broad product portfolio includes flow cytometry, cell biology, and functional reagents for research in immunology, cancer research, stem cells, and more. The aggressive product development program is accomplished through technology licensing, collaborations, and internal research. BioLegend offers a wide range of custom services including assay development, sample testing, and conjugation. BioLegend was incorporated in June 2002 with headquarters in San Diego, CA.