TMCnet - World's Largest Communications and Technology Community

» More Appliance Deployment Feature Articles

Appliance Deployment Featured Article

October 22, 2012

Appliance Deployment Provider NEI Earns ISO 13485 Medical Device Certification

By Rajani Baburajan, TMCnet Contributor

NEI (News - Alert), a provider of appliance deployment platforms, solutions and lifecycle support services for software technology developers and OEMs worldwide, has just received the ISO 13485:2003 Medical Device Quality Management System certification at its manufacturing facility in Canton, Mass.

This certification was awarded to the company for its stringent quality management system and commitment to engineering excellence that meets regulatory requirements.

The ISO 13485:2003 standard recognizes an organization’s 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.

The appliance deployment provider also adheres 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, in a statement.

“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,” Gauthier added.

Further, the company’s commitment to frequent audits, evaluation of its manufacturing protocols, and maintaining a constant dialog with customers and suppliers to ensure that requirements and specifications are fully met were all vital factors that contributed towards the organization earning this recognition.

“Our employees adhere to a robust quality management system in support of NEI’s commitment to excellence in medical device engineering,” Gauthier commented.

In another recent development, NEI was selected by Lightspeed Systems, Inc. to manufacture its new Bottle Rocket (News - Alert) school network filtering appliance. Utilizing NEI’s solution design and system integration services, Lightspeed Systems was able to develop and launch its Bottle Rocket appliance in less than 60 days.

Edited by Jamie Epstein

» More Appliance Deployment Feature Articles

Related content you may also be interested in…
A computing entity that delivers predefined service(s) through an application-specific interface with no accessible operating software
Definition of an Appliance
Gartner, Inc.

White Papers

How to Deliver Software as a Purpose-Built Appliance
Gaining the Business Benefits, Avoiding the Pitfalls
Energy Star Specifications for Enterprise-Class Servers
What Application Software Vendors Need to Know and Why the Intel® Xeon® 5500 Microarchitecture Will Help Achieve Compliance

Success Stories

Endace Selects NEI to Support Rapidly Growing Systems Business
Endace is a leading provider of next-generation, high-speed network monitoring and recording systems. Its solutions are guaranteed to capture 100% of packets at speeds up to 100 Gb/s and easily optimized for a wide range of monitoring and security applications.
NEI Enables Alert Logic to Scale its Business by More Than 40%
The task of securing enterprise data and ensuring compliance can be daunting, particularly as the use of mobile devices grows and computing environments evolve.
Bringing Cross Domain Security from Software to Hardware
ITT-AES Chooses NEI for a Comprehensive Approach to Product Development
Modus Operandi: Taking Email Security to the Next Level
NEI Brings Flexibility and Cost-Effectiveness to Vircom's ModusGate Solutions


Thrive in '09 - Strategies for Success with Intellitactics
Learn how to gain market share, increase efficiencies and reduce costs
Thrive in '09 - Strategies to Increase Efficiencies and Keep Costs Down Featuring Vircom
Learn how to gain market share, increase efficiencies and reduce costs
NEI speaks out on Energy Star server ratings
Listen to eWEEK's podcast with NEI about the impact of Energy Star ratings on servers
Implementing Smart Services
Learn how smart services can improve lifecycle management, reduce operating expenses and grow revenue

blog comments powered by Disqus

Technology Marketing Corporation

35 Nutmeg Drive Suite 340, Trumbull, Connecticut 06611 USA
Ph: 800-243-6002, 203-852-6800
Fx: 203-866-3326

General comments:
Comments about this site:


© 2017 Technology Marketing Corporation. All rights reserved | Privacy Policy