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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Proposed US FDA Program Targets Medical Device Supply Chain Shortages
A new program proposed by the US Food and Drug Administration would bolster domestic supply chains for medical devices during public health emergencies, but would also entail additional compliance work for manufacturers.
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