DeviceLab Gets ISO 13485 Certification

DeviceLab Inc., an Orange County, CA, medical product design and product development company, has received ISO 13485 certification from the International Organization for Standardization.

ISO 13485 is an internationally recognized standard developed to ensure that a medical device design company develops and manufactures medical devices that meet specific quality requirements. More specifically, it is a Quality Management System (QMS) standard specifically developed for the manufacture of medical devices.

The standard contains specific requirements for medical device manufacturing, installation and servicing, including:

• Implementation of a Quality Management System (QMS) with several enhancements
• Risk Management approach to medical product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

"ISO 13485 certification is proof of DeviceLab's commitment to quality," says DeviceLab founder and CEO Dac Vu. "This certification aligns DeviceLab's 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."

Vu states that DeviceLab 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.

"DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing," Vu says. "We look forward to leveraging our new ISO 13485 to provide our unique suite of medical device development services in the coming months and years."