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Nexcore Regulatory and Quality functions are an integral part of Nexcore's business systems. They support the full spectrum of services provided from R & D through manufacturing, quality, sourcing, regulatory submissions and compliance.
The Quality Systems are in compliance with FDA QSR and Nexcore is certified to International Standards ISO 13485 and ISO 9001. These Quality Systems are adaptive to the needs and requirements of the most demanding OEM companies. The Regulatory framework is structured to partner with our customers' product development needs to ensure regulatory issues are managed and compliant.
Nexcore's quality procedures ensure regulatory compliance from product development through manufacturing and marketing. After market services, such as customer service, repair & complaint handling, are addressed as well.
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