EUDAMED-supports transparency and traceability- it is the European database for medical devices and is a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. It is coming with mandatory usage from Q4 2025. Those involved in Medical Device development need to be ready and prepared to use EUDAMED correctly. This session will highlight some of the pitfalls, experiences to date, and what is actually needed to submit your data to EUDAMED.
Registration Fees & Deadlines
Free
Date
December 5th, 2024 at 5:30- 6:45 PM GMT
RAC Credit
0
Speakers
Richard Houlihan
EUDAMED Deadlines, Experiences and Pitfalls, EIRMED
Richard Houlihan is a leading authority on EUDAMED. Richard is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him and his company a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.
His company EirMed with the website eudamed.com provides ongoing EUDAMED and regulatory submission software for both EUDAMED and GUDID, with more in the pipeline. Other services include EUDAMED attribute analysis, project management, consultancy, training, and an EUDAMED mobile search app to help the industry meet its EUDAMED label-checking obligations. To date, Richard and his team have trained over a thousand people on EUDAMED, helped countless companies with EUDAMED consultancy, and support, and uploaded thousands of UDI DIs to EUDAMED.
Questions
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