The United States is the world’s largest medical device market, highly innovative, commercially rewarding, and rigorously regulated. Governed by the U.S. Food and Drug Administration (FDA), manufacturers must comply with requirements such as establishment registration, device listing, FDA clearance or approval (510(k), PMA, or De Novo), quality system regulations (QSR). Devices must carry a UDI label and submit primary device identifier data to the FDA’s Global UDI Database (GUDID). At Obelis, we provide strategic and regulatory support to help you navigate the FDA approval process, ensure ongoing compliance, and successfully launch your devices in the U.S. healthcare landscape.