AMDI Achieves ISO 13485:2016 Certification In Anticipation of Commercializing Products in 2023

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Autonomous Medical Devices Incorporated

Sep 07, 2022, 12:50 ET

SANTA ANA, Calif., Sept. 7, 2022 /PRNewswire/ -- Autonomous Medical Devices, Inc. (AMDI) announced today the certification of its Quality Management System to ISO 13485:2016 by Intertek. This certification is an important milestone, particularly as the Company prepares for commercialization of its first rapid, point-of-care diagnostics platform.

"We are proud to receive this ISO certification. At AMDI, Quality is built into every process and embraced by every employee," said Aiying Sun, VP Quality Assurance and Regulatory Affairs.

ISO 13485:2016 specifies requirements for an organization's Quality Management System to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements.

"The ISO certification is an important recognition of AMDI's commitment to develop and manufacture high quality diagnostic products using our breakthrough technology," explained David Okrongly, CEO of AMDI.

About AMDI

Autonomous Medical Devices Incorporated (AMDI) is an early-stage, California company focused on developing and manufacturing Autolabs and their associated test discs for human clinical diagnostics. Each of AMDI's Autolabs are small, portable point-of-care diagnostics devices using breakthrough microfluidics, hardware, and data/cloud connectivity to deliver lab quality results in <15 minutes. AMDI has built a world class, multi-disciplinary team of engineers, scientists, clinicians, and database experts and will launch its first Research Use Only (RUO) products in 2023 from its 110,000 square foot facility in Santa Ana, CA.

Media Contact
Brian Miller
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SOURCE Autonomous Medical Devices Incorporated