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Medical Device Market Access Consulting

Medical Device Market Access

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

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Regulatory consulting for medical devices and IVDs

Our consulting team has supported our customers with thousands of medical device and IVDs projects.

  • We help medical device and IVD companies register their products in more than 20 countries, including Australia, Brazil, Europe, Japan and the U.S.
  • Over 150 consultants globally
  • Diverse product experience and specialized areas of focus to solve your toughest challenges

Medical device market access services

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Regulatory affairs 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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Software development consulting

Leverage our expertise to help you achieve regulatory compliance and start selling your medical device in global markets.


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Global regulatory M&A services

Our expertise supports regulatory compliance that is seamlessly integrated into your Mergers and acquisitions (M&A) strategy, facilitating smooth transitions and helping to preserve the value of your transactions.

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RAMS®: Regulatory Management Affairs Suite

Introducing RAMS, Regulatory Affairs Management suite, a digital platform for global market access.

Leveraging more than 20 years of regulatory experience, we developed our digital platform to enable regulatory intelligence, research and more.

Find out what RAMs can do for you!

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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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