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 lighting,
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.
