Excelitas Technologies’ LED Facility in U.S. Receives ISO 13485:2003 Certification
Certification strengthens Excelitas’ capabilities to serve light engine needs of medical device customers worldwide
Excelitas Technologies, a global provider of innovative, customized optoelectronics to OEMs seeking high-performance technology solutions, announced today that its LED-based manufacturing facility in Wheeling, Ill. has achieved ISO 13485:2003 certification. ISO 13485:2003 certification is an internationally recognized quality standard designed to ensure that medical device manufacturers and critical component suppliers to medical device manufacturers have the required quality management systems in place to safely design, manufacture and distribute medical devices as well as the critical components incorporated into these devices.
As a light engine manufacturer serving medical device OEMs worldwide, Excelitas is now one of the few components and subsystems-based companies with multiple manufacturing sites that are ISO 13485:2003-certified. The company’s Fremont, Calif. facility, which manufactures Xenon-based light engines for the medical industry, received certification in 2009.
Applications for Excelitas’ LED and Xenon-based medical lighting technologies include surgical suite lighting, surgical headlamps, dental lighting, endoscopy, robotically-assisted minimally invasive surgery, photodynamic therapy for newborns, and more.
“We are extremely proud that Excelitas’ LED Solutions facility in Wheeling, Ill. has achieved ISO 13485:2003 certification, validating the strong focus on quality management systems that our global customers have come to rely on and expect from our organization,” said Joel Falcone, senior vice president and general manager of Excelitas Technologies’ global lighting business. “Receiving this certification strengthens our opportunity to meet the stringent, evolving needs of medical OEMs worldwide and helps them accelerate their time-to-market with innovative designs incorporating our LED-based solutions.”
Excelitas has ISO-certified component and subsystem design and manufacturing sites in the U.S., Europe and Asia.
About Excelitas Technologies
Excelitas Technologies is a global technology leader focused on delivering innovative, customized solutions to meet the illumination, detection and other high-performance technology needs of OEM customers. From medical lighting to analytical instrumentation, clinical diagnostics, industrial, safety and security, and aerospace and defense applications, Excelitas Technologies is committed to enabling our customers' success in their specialty end-markets. Excelitas Technologies has approximately 3,000 employees in North America, Europe and Asia, serving customers across the world. The company was previously the Illumination and Detection Solutions (IDS) business unit of PerkinElmer, and is now owned by Veritas Capital.