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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UK MHRA Provides Registration Requirements for IVDs Undergoing Performance Evaluation
The United Kingdom's medicines and healthcare products regulatory agency, (MHRA) updated its medical device and IVD registration guidance to include a section on IVDs undergoing performance evaluation.
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