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 help our customers get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.
Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their 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.
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US FDA Rolls Out List of Registered Medical Devices Featuring Artificial Intelligence and Machine Learning
FDA regulators have published a searchable list of medical devices incorporating artificial intelligence and machine learning (AI/ML) to promote transparency. Learn more about US FDA regulations at Emergo by UL.
Australia TGA to Accept CE Mark Conformity Assessments for Some High-Risk Medical Devices, IVDs
The therapeutic goods administration (TGA) will accept conformity assessments from European notified bodies for some Class III medical devices, active implantable devices and Class 4 IVDs submitted for registration in Australia. Learn more at Emergo by UL
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