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.”