Quality Certifications

ISO 13485:2016 Certification

ISO 13485:2016 certification is an internationally recognized standard that confirms a company's quality management system is compliant with the requirements for medical devices. It demonstrates that the company's medical devices and services consistently meet customer expectations and applicable regulations.
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FDA Registered

FDA registration is a set of mandates that regulate manufacturing operations for facilities involved in the production and distribution of medical devices in the United States. It determines whether a facility has the appropriate resources, including equipment and personnel, to perform the manufacturing operations.

ITAR Compliant

ITAR is administered and implemented by the Directorate of Defense Trade Controls (DDTC) in the Bureau of Political-Military Affairs at the U.S. Department of State. The US arms traffic regulation controls the manufacturing, sales, distribution, access, use, export, and temporary import of military or defense-related goods, services, software, and related plans or documentation (technical data) covered on the United States Munitions List (USML).

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