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