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 Seeks Stakeholder Comment on Regulatory Approaches to 3D Printed Medical Devices
US FDA issues potential regulatory framework for 3D printed medical devices at the point of care (PoC). Learn more about FDA's approach to 3D printed medical devices and additive manufacturing at Emergo by UL.
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