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 Revokes Emergency Use Authorizations (EUA) for Some Personal Protective Equipment (PPE)
US regulators have revoked emergency use authorizations for some non-NIOSH-approved personal protective equipment (PPE) as the country's COVID-19 public health emergency situation evolves. Learn more at Emergo by UL.
US FDA Aims to Improve Cybersecurity Related to Servicing and Maintenance of Medical Devices
FDA seeks feedback from stakeholders on four key cybersecurity issues associated with servicing of medical devices. Learn more about US FDA medical device cybersecurity regulations at Emergo by UL.
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