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Services

 

  • Providing comprehensive U.S. Agent services for foreign medical device establishments in accordance with FDA requirements

 

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Experience

 

  • Supported by experienced senior leadership with extensive medical device industry expertise and a strong understanding of FDA requirements and U.S. market entry

 

 FDA Requirements

 

  • Foreign medical device establishments that manufacture, prepare, propagate, compound, or process devices imported or offered for import into the United States are required to designate a U.S. Agent

 

 

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