I3CGlobal offers reliable EU Representative services for medical device and IVD manufacturers operating outside the European Union. Their team ensures full regulatory alignment with MDR and IVDR requirements, including vigilance reporting, documentation management, and regulatory communication. With deep European expertise, I3CGlobal acts as your trusted regulatory link, helping maintain compliance, avoid penalties, and achieve smooth market entry. Manufacturers depend on their accuracy, responsiveness, and commitment to meeting evolving EU regulations.
