RAF Solutions USA

(Hall 16 / Stand F02 / Booth 07)

RAF Solutions USA, Inc.
10124 NW 53rd Street
Sunrise, Florida 33351 U.S.A

Phone: +1.305.960.7262

Contact: John Gargaro, President
Email: john.gargaro@rafsolutions.net


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. Additionally we also provide risk management and insurance needs analysis. 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.