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Sypris Electronics, LLC has achieved ISO 13485:2016 recertification from NSF-ISR, an NSF International company. The ISO 13485 standard is the quality management systems standard for the medical device industry.
Based on the ISO 9001 process approach to quality management, the primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services.
By maintaining the ISO 13485 certification through NSF-ISR, Sypris Electronics LLC demonstrates a commitment to continual improvement of either manufacturing or service processes helping to ensure the safety and effectiveness of medical devices.