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Medical Device Market Access Consulting

Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997.

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RA/QA consulting

Leverage our expertise to solve complex regulatory challenges. We will design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide.

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Device registration

We utilize years of hands-on experience to help our customers get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.

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In-country representation

Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their device registrations.

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Post-market surveillance

We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.

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RAMS portal registration

Looking for EU MDR help?

Visit our MDR Resource Center to meet our MDR team and get free educational resources on the MDR.

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