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.
It demonstrates our commitment to
maintaining the highest standards of quality and safety in our
products
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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SOURCE Alamar Biosciences, Inc.