DeviceLab founder and CEO Dac Vu said this certification aligns its management system to the requirements of the FDA’s quality system regulation (QSR) requirements, as well as many other regulatory requirements found throughout the world.

"It currently has two active medical device design projects that are being developed under the auspices of ISO 13485, and expects more projects to soon be launched," Vu said.

"We look forward to leveraging our new ISO 13485 to provide our suite of medical device development services in the coming months and years."