We serve the Medical device community to assist them with the rigorous process of quality management, testing and preparing the documentation to submit to the FDA for clearing a Medical device to sell in the US market.
We are located in Shanghai, China and also in the United States to professionally service your needs in both countries.
We will assist you with your regulatory needs, we have the experience to assist you.
We have teamed with test labs to assist you with you testing needs. Our US office.
Our expert engineering staff will assist you. We have years of experience to help guide you through the regulations.
Foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported, or offered for import, into the U.S. must register their establishments and provide the FDA with the name of the U.S. agent representing their establishment.
Premarket Notification 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA).
A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA).