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 Medical Device Regulators Extend UKCA Transition Plan by One Year
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially delayed implementation of planned medical device regulations by 12 months in order to avoid potential supply disruptions and allow more time for preparing necessary systems.
New European Guidelines on Notified Body Surveillance Obligations Under the IVDR
The European Commission’s Medical Device Coordination Group (MDCG) has published guidance covering surveillance activities required of Notified Bodies under Article 110 of the In Vitro Diagnostic Medical Devices Regulation (IVDR).
New European Manual on Borderline and Classification for Medical Devices and IVDs Issued
European Commissioners have published a highly anticipated new version of the Manual on Borderline and Classification for medical devices under the Medical Devices Regulation (MDR) and for in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Med
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