Sell your medical device in the U.S.? You’ve got an agent now.
If your business is based outside of the United States and you plan to sell your medical device in the U.S., you must identify a U.S. agent as part of the establishment registration process. QUARA can serve as a communications bridge between your leadership team and the FDA on all FDA quality and regulatory matters. We work extensively with companies like yours across the globe, helping secure the proper registrations and ensuring that systems meet quality requirements that the FDA demands.
Establish a U.S. Agent.
As your U.S. agent, QUARA can help manage communications with the FDA, respond to questions concerning imported medical devices and assist with scheduling FDA inspections. The FDA can funnel communications through QUARA to your business.
Go to the U.S. market.
You’ll need a trusted partner to help you navigate FDA requirements and fulfill regulatory obligations. As a foreign establishment, communicating with the FDA and other entities can be a challenge. QUARA can act as the U.S. Agent or FDA Official Correspondent for your international medical device company.