DeviceLab Gets ISO 13485 Certification
Summary
"DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing," said Vu.A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services.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 DeviceLabs commitment to quality," said DeviceLab founder and CEO Dac Vu."DeviceLab has a solid QMS in place, commitment from top management, and controlled processes and procedures established for world-class design and manufacturing," said Vu.On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.For more information about ISO, please visit http://www.iso.org.About DeviceLabDeviceLab is a contract medical device design and product development firm in Orange County, California.A full-service company, DeviceLab has expertise in mechanical engineering, electronics, software, industrial design, prototyping, manufacturing, FDA regulatory consulting and product testing services.