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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Get the latest industry insights from our Market Access experts.
Brazilian Regulators Update Economic Monitoring Requirements for Some Medical Devices
Brazilian medical device regulator ANVISA has issued new regulations regarding economic monitoring of certain device types in order to boost transparency and establish reference pricing for these products.
Guidelines Released for Transition in Philippines to ASEAN Harmonized Requirements
The Food and Drug Administration (FDA) of the Philippines published Circular No. 2021-002, providing for further implementation of the Association of Southeast Asian Nations (ASEAN) regulatory framework for medical devices.
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