We support manufacturers of medical devices and IVDs to address challenging regulatory issues.
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
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.Learn more
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.Learn more
Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their device registrations.Learn more
We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.Learn more
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.
Get the latest industry insights from our Market Access experts.
New Brazil INMETRO Ordinance Eases Inspection and Documentation Requirements
In Brazil, a new ordinance was published by the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), providing updated conformity assessment standards and documentation requirements.
US FDA Unveils Next Steps for Regulating Artificial Intelligence-Based Medical Software
US regulators explain evolving approach to oversight of SaMD based on artificial intelligence and machine learning. Learn more about FDA regulation of medical software and healthcare cybersecurity at Emergo by UL.
Canadian Regulatory Amendments Introduce Expanded Post-Market Surveillance Provisions
New amendments published by Health Canada impose stricter requirements for medical device manufacturers and greater powers for regulatory authorities relating to post-market surveillance and risk management.
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