September 7, 2022

Santa Ana, CA

Autonomous Medical Devices (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.

AMDI Media Contact:
Brian Miller
media@amdilabs.com