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 Readies Transition Plans for COVID-19 Medical Device Enforcement Policies
New guidance from the US Food and Drug Administration explains a phased transition plan for medical devices currently covered by agency enforcement policies devised to address the COVID-19 public health emergency.
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