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.