Summary: Cytek Biosciences’ San Diego reagent manufacturing facility has earned the EN ISO 13485:2016 certification, underscoring the company’s commitment to high-quality standards in the design, development, manufacturing, and distribution of reagents.
Takeaways:
- Global Quality Standard: The EN ISO 13485:2016 certification of Cytek’s San Diego facility, along with its other manufacturing sites in China and California, demonstrates the company’s adherence to internationally recognized quality management standards in the medical device industry.
- Market Expansion: This certification is a significant milestone for Cytek as it supports their planned entry into the U.S. clinical market, enhancing their ability to provide clinical-grade reagents for flow cytometry and potentially driving revenue growth.
- Commitment to Excellence: The certification, awarded by TÜV Rheinland after a thorough audit, reflects Cytek’s dedication to rigorous quality standards, reassuring customers of the reliability and safety of its products as it continues to expand its global market presence.
Cytek Biosciences 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.
About ISO 13485 Certification
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 product safety and reliability. ISO 13485 certification also facilitates access to international markets by aligning with various regulatory requirements.
Reagents for Flow Cytometry
Cytek’s comprehensive suite of reagents are tailored for flow cytometry applications. To harmonize processes and respond swiftly to market demands and technology advancements, Cytek recently moved its reagent manufacturing from its Fremont headquarters to San Diego. The San Diego facility manufactures Cytek’s cFluor, Guava, Muse and Tonbo reagents.
“Receiving ISO 13485 certification is a major step in our journey toward making clinical grade reagents readily available and sets the foundation for our continued market expansion,” says Chris Williams, chief operating officer for Cytek Biosciences. “This certification is a testament to the hard work and dedication of our team, who have worked tirelessly to meet stringent quality standards. It reassures our customers of our commitment to providing high-quality products. We anticipate that our planned expansion into the clinical market in the U.S. will enhance our service offerings and contribute to our revenue growth.”
The EN ISO 13485:2016 certification was awarded following a thorough assessment and audit of the facility’s QMS by TÜV Rheinland, a leading independent certification body. Currently, Cytek’s products are approved for clinical and diagnostic use in China and the European Union. The achievement of ISO 13485 certification is a crucial step towards Cytek’s entry into the U.S. clinical market.
