FDA is a federal agency of the United States Department of Health and Human Services. The systems provided for the U.S market have been registered and hold an FDA 510(K) when applicable.
Cofepris is a regulatory body of the Mexican government that is responsible for regulating a variety of health related topics in Mexico, including medical devices.
ISO 13485 is a quality management system for the design and manufacture of medical devices. We have been assessed and found in compliance with ISO 13485:2016. As a result, our facility proudly has this certificate hanging in our front lobby.
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