Cytek Biosciences achieves ISO 13485 Certification at headquarters

Cytek Biosciences has received EN ISO 13485:2016 Quality Management System certification. The certification applies to Cytek’s headquarters and manufacturing operations in Fremont, California for the design, development, manufacturing, distribution, installation and service of flow cytometers, reagents and accessories. The company’s manufacturing facilities in Wuxi, China are also EN ISO 13485:2016 certified. ISO 13485 is the global standard established by the international standards organization to ensure that medical devices meet the proper regulatory compliance laws to keep professionals and customers in clinics, hospitals and other medical settings safe.