NEI Achieves ISO 13485 Medical Device Certification
Poster: SySAdmin
Posted on October 22, 2012 at 9:21:02 AM
NEI Achieves ISO 13485 Medical Device Certification
Stringent Quality Management System and Commitment to Engineering Excellence Meets Market's Regulatory Requirements
CANTON, Mass., Oct. 22, 2012 /PRNewswire/ -- 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 http://www.nei.com.
NEI and the NEI logo are trademarks of Network Engines, Inc. All other names, brands and trademarks are the property of their respective holders.
For additional information, contact:
Jill Colna or Laura Nelson
SVM Public Relations
401-490-9700
jill.colna@svmpr.com
laura.nelson@svmpr.com
SOURCE NEI
NEI
Web Site: http://www.nei.com
Stringent Quality Management System and Commitment to Engineering Excellence Meets Market's Regulatory Requirements
CANTON, Mass., Oct. 22, 2012 /PRNewswire/ -- 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 http://www.nei.com.
NEI and the NEI logo are trademarks of Network Engines, Inc. All other names, brands and trademarks are the property of their respective holders.
For additional information, contact:
Jill Colna or Laura Nelson
SVM Public Relations
401-490-9700
jill.colna@svmpr.com
laura.nelson@svmpr.com
SOURCE NEI
NEI
Web Site: http://www.nei.com