Certifications

ISO 9001:2008 Certification 

ISO 9001:2008 certification confirms that our organization meets the specific standards of a quality management system. This is achieved by demonstrating the ability to consistently provide product that meets customer and applicable regulatory requirements. We aim to enhance customer satisfaction through the effective application of the system, including processes for continual improvement and the assurance of conformity to customer and applicable regulatory requirements.

ISO 9001:2008 Certificate (PDF)

FDA

In the U.S., shipment of temperature-sensitive articles is regulated by the Food and Drug Administration (www.fda.gov). 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. In addition to complying with general controls, Class II devices are also subject to special controls.  Special controls may include special labeling requirements and mandatory performance standards.

Consumer Product Safety Certification

The product certification letters below are provided in accordance with the Consumer Product Safety Improvement Act of 2008 (CPSIA):

 

 

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