US Flag and Compass

US Market Entry Compass

Your quick start to launching medical and IVD medical devices in the US market

Get an overview of the FDA requirements to quickly and safely launch your medical and IVD medical devices in the US market. 

 

Request free of charge

Quick Overview and Clarity

Save yourself the research work. Here, you will find a compact overview of the market entry process in the USA and the FDA's requirements.

Efficient Planning

Find out what the FDA requires, which tasks must be completed, and when. This way, you can esti­mate the costs and duration of the market entry.

Assurance and Legal Certainty

Avoid costly rework and legal issues by imple­menting FDA requirements completely and correctly from the outset. 

The free US Market Entry Compass includes:

  • Step-by-step guide to the US market entry process 
  • Overview of key documents and FDA requirements 
  • Final checklist for US market entry and FDA submissions 
  • Recommendations for training and links to further educational resources 

Request your US Market Entry Compass

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