Huntersville, NC facility Achieves ISO 13485:2003 – Based on ISO 9001, ISO 13485 incorporates additional quality management requirements relating to design, development, production, and installation of medical devices and related services, with focus on meeting regulatory requirements, risk management, and maintaining effective processes.
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Keller ISO Quality Management Certifications
Buffalo: ISO 9001
Charlotte: ISO 9001, ISO 13485