RAF Solutions, Inc., understands that entering the U.S. market is challenging and expensive for a manufacturer. The complexity and cost of setting up an office and all 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, and invoicing, and inventory control. As your business expands, we work in partnership to tailor the resources and costs needed to sustain your growth. RAF is with you every step of the way.
Contact: www.rafsolutions.net