FREMONT, Calif., July 25, 2024 /PRNewswire/ — Alamar Biosciences, a company powering precision proteomics to enable the earliest detection of disease, today announces that it has successfully achieved ISO 13485:2016 certification. This internationally recognized standard for quality management systems is specific to the medical devices industry and signifies Alamar Biosciences’ dedication to providing the highest quality products and services to its customers.
The ISO 13485:2016 certification is a critical milestone for Alamar Biosciences, reflecting the company’s rigorous quality control processes and adherence to the stringent regulatory requirements necessary for the design, development, and manufacture of medical devices. This achievement underscores Alamar Biosciences’ commitment to excellence, safety, and continuous improvement.
“We are proud to have achieved ISO 13485:2016 certification at such an early point in our company’s history,” said Yuling Luo, Ph.D., Chairman, Founder and CEO of Alamar “This certification is a testament to the hard work and dedication of our entire team. It demonstrates our commitment to maintaining the highest standards of quality and safety in our products, ensuring that we meet the needs of our customers and the regulatory requirements of the medical device industry.”
The certification process involved a thorough evaluation of Alamar Biosciences’ quality management system, including detailed assessments of its policies, procedures, and practices. The successful certification confirms that Alamar Biosciences operates in compliance with the ISO 13485 standard, providing a strong foundation for its ongoing growth and innovation in the biotechnology field.
Alamar Biosciences is dedicated to advancing the field of proteomics through innovative research and development. The company recently commercialized the ARGO™ HT System and NULISA™ assays for fully automated and highly sensitivity detection of protein biomarkers from biofluids. With the ISO 13485:2016 certification, the company is well-positioned to continue its mission of powering precision proteomics to enable the earliest detection of disease.
About Alamar Biosciences, Inc.
Alamar Biosciences is a privately held life sciences company with a mission to power precision proteomics to enable the earliest detection of disease. The company’s proprietary NULISA Platform along with the ARGO HT System work seamlessly with the latest advances in genomics to achieve single digit attomolar detection sensitivity, greatly surpassing the most sensitive protein detection technology on the market today. For more information, please visit alamarbio.com.
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