TM
Redefining Application DeploymentPress Release
NEI / 25 Dan Road Canton, MA / 02021-2817 / telephone: 781 332 1000 / fax: 781 770 2000 www.nei.com
NEI Achieves ISO 13485 Medical Device Certification
Stringent Quality Management System and Commitment to Engineering Excellence Meets Market's Regulatory Requirements
CANTON, Mass, October 22, 2012 - NEI, a leading provider of
application platforms, deployment solutions and lifecycle
support services for software technology developers and OEMs
worldwide, today announced that it has achieved the ISO
13485:2003 Medical Device Quality Management System
certification at its manufacturing facility in Canton, Mass.
The objective of ISO 13485:2003 is to facilitate harmonized
medical device regulatory requirements for quality management
systems, and its requirements are unique to organizations
building medical devices.
The ISO 13485:2003 standard requires an organization to
demonstrate its ability to provide medical devices and
related services that consistently meet customer and
regulatory requirements applicable to medical devices and
related services. To meet the criteria of the ISO
13485 standard, NEI developed and implemented a comprehensive
range of policies used to maintain its quality management
system for medical devices, including an internal quality
policy to ensure customer requirements are identified and
fulfilled in the solution design and production cycles.
Additionally, NEI must adhere to a variety of quality
controls, including the validation of production and service
processes, the validation of monitoring and measuring
devices, and by conducting risk assessments of certain
process changes.
"NEI recognizes the strict parameters and regulatory
requirements involved in medical device manufacturing and has
developed rigorous practices in support of those metrics,"
said John Gauthier, director of quality assurance at NEI.
"Central to achieving ISO 13485:2003 certification is NEI's
commitment to frequent audits, management's evaluation of its
manufacturing protocols, and maintaining a constant dialog
with customers and suppliers to ensure that requirements and
specifications are fully met. Our employees adhere to a
robust quality management system in support of NEI's
commitment to excellence in medical device engineering."
NEI's unique server lifecycle expertise and support services
reduce costs and simplify hardware deployment and management
challenges.
As experts in engineering and managing healthcare IT
platforms, NEI has become the integration support partner of
choice for market leaders worldwide. With a controlled
component management system, NEI healthcare IT application
platforms provide extended-life solutions necessary for the
highly regulated and controlled healthcare IT industry.
About NEI
NEI, a wholly-owned subsidiary of Unicom Global, is a leading provider of server-based application platforms and lifecycle support services for software developers and OEMs worldwide. Through its expertise and comprehensive suite of solution design, system integration, application management, global logistics, support, and maintenance services, NEI is redefining application deployment solutions to provide customers with a sustainable competitive advantage. More than a decade of appliance innovation with the ability to provide physical, virtual and cloud-ready solutions makes NEI one of the most trusted software deployment partners in the industry. Founded in 1997, NEI is headquartered in Canton, Massachusetts, with facilities in Plano, Texas and Galway, Ireland. For more information, visit www.nei.com .
NEI and the NEI logo are trademarks of Network Engines, Inc. Intel and Xeon are registered trademarks of Intel Corporation. All other names, brands and trademarks are the property of their respective holders.
Editorial Contacts:
Jill Colna or Laura Nelson
SVM Public Relations
401-490-9700 jill.colna@svmpr.com laura.nelson@svmpr.com
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