One of the FDA's many requirements is that all medical device and IVD companies without a presence in the US must appoint a registered US Agent. This person must be a resident of the United States or maintain a physical place of business in the US, which makes RQMIS a perfect fit.
The EU has a similar requirement where a representative must be designated by non European Union (EU) manufacturers to represent them in the EU and ensure their compliance with the European Directives - this representative is called an Authorized Representative or AR for short.
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