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Emergo by UL offers digital applications, human factors engineering (HFE) platform, Optimal Product Usability Suite (OPUS) and Regulatory Affairs Management Suite, RAMS.
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Medical Device Registration - Mexico Updates
In this complimentary webinar, we will examine current medical device registration requirements in Mexico and recent regulatory changes.
Software as a Medical Device (SaMD): EU/US Regulatory Considerations
In this webinar, we provide information on considerations for designing and classifying SaMD in the United States and European Union.
European Countries that Require CE Marking
The European Union comprises 28 countries that require CE Marking. Emergo by UL can assist you in obtaining CE Marking so you can sell your medical device in any of these European countries.
Israel Registration Holder for Device and IVD Companies
Emergo, with offices in Israel and worldwide, acts as an independent regulatory representative for medical device and IVD manufacturers.