Certifications

ISO 9001

Our certification requires specific requirements for a quality management system where our organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements.

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FDA

Our facility produces Class II devices for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.

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CPSIA

Consumer Product Safety Improvement Act of 2008 (CPSIA)

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