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.
South Korea MFDS Plans Several Medical Device Regulatory Updates for 2022
The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, plans to roll out several amendments to the country’s Medical Devices Act over the course of 2022, and has also expanded its list of devices eligible for electronic
New Guidelines Published on Integrating UDI Into Quality Management Systems Under MDR, IVDR in Europe
The European Medical Device Coordination Group (MDCG) has published new recommendations for medical device manufacturers on integrating Unique Device Identification (UDI) data into their quality management systems
Learn from our experts through live webinars, workshops, and tradeshows.