In order to become certified, NEI had to develop and implement a comprehensive range of policies and procedures, including an internal quality policy that ensures customers’ needs are understood and included in the solution design and production phases of the device. As part of its quality program, NEI has also developed checks and controls to validate production and service processes, conduct risk assessments as they relate to specific process changes, and validate measuring and monitoring devices.
To maintain certification, the company has committed to perform internal and third-party led audits of its quality system, regular management reviews of production protocols, and frequent audits for quality and compliance with both customers and suppliers. The standard set forth for medical device manufacturers requires a quality commitment from employees as well, something the workforce at NEI’s Canton, MA facility had no problem buying into.
The rigorous practices and procedures developed by NEI to build a quality program underscores its understanding of the strict regulations surrounding medical devices and its desire to comply with those regulations. It also gives the company a chance to demonstrate to customers its commitment to engineering excellence in everything it designs and builds, including medical IT systems. By achieving certification, the organization is positioned to become one of the top medical device manufacturers globally.
The unique expertise NEI provides in server lifecycle management and support services translate directly to reduce costs and fewer management issues for OEMs and software developers around the world. The company has become a partner of choice for many market leaders in integration support. With the addition of its new medical device certification quality management system, NEI’s healthcare IT application platforms provide the extended-life solutions sought by application developers in this tightly controlled and highly regulated field.
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