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
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.
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!
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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