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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Options for Medical Device Companies to Appeal US FDA Regulatory Reviews and Decisions
FDA guidance outlines appeal options for medical device industry stakeholders disputing regulatory decisions and actions by the Center for Devices and Radiological Health (CDRH). Learn more at Emergo by UL.
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