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.
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.
US FDA Roundup: Final De Novo Rule, GUDID for Class I Medical Devices, Reclassification of Surgical Staples
US regulators have issued final rules for de novo novel device classification requests and up-classification of surgical staplers, as well as updated GUDID submission requirements for some class I devices. Learn more at Emergo by UL.
Learn from our experts through live webinars, workshops, and tradeshows.