Cytek® Biosciences Achieves ISO 13485 Certification at San Diego Reagent Manufacturing Facility
Cytek Biosciences, Inc. (CTKB)
Company Research
Source: GlobeNewswire
FREMONT, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification encompasses the design, development, manufacturing, and distribution of reagents and accessories, highlighting the company's adherence to rigorous quality standards. Cytek’s manufacturing facilities in Wuxi, China and its headquarters in Fremont, California are also EN ISO 13485:2016 certified. ISO 13485 is a globally recognized standard that outlines the requirements for a comprehensive QMS specific to the medical device industry. It is crucial that medical devices meet consistent quality and regulatory requirements, which are essential for patient safety and effective healthcare delivery. The standard covers all aspects of a product's lifecycle, from initial design and development through production and distribution, to promote
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