Emergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997. We maintain offices in 25+ countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation.
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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.
We utilize years of hands-on experience to ensure our clients get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.
We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.
How We Help
We have helped our clients expand their reach to major device markets worldwide.
The medical device and IVD regulatory landscape has evolved. Learn how Emergo by UL's global market access team helps device companies navigate changing regulatory demands and stay on the market.
