RAF Solutions USA
(Hall 16 / Stand F02 / Booth 07)
Entering the U.S. market is challenging and expensive for Manufacturer’s. The complexity and cost along with the regulatory requirements of the FDA can be a daunting and lengthy process. We take your needs and turn them into solutions. Our expertise includes acting as Initial importers and/or US Agent, regulatory assistance for your device registrations, FDA clearance 510(k), 513(g), and Pre-IDEs and FDA approval, FDA Establishment registration, import and warehousing, full customer service, order fulfillment, invoicing, and inventory control.
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