Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape

In this episode of The Factor Podcast, industry experts Dr. Christiana Hofmann and Richard Houlihan discuss the complexities of Unique Device Identification (UDI) compliance in the evolving European regulatory landscape. From the daunting task of collating data to the importance of strategic planning, they reveal the critical factors that can make or break a successful UDI implementation. Join the conversation as they shed light on the need for collaboration, the impact of AI on data reporting, and advice for manufacturers to scale the mountain of UDI compliance.

AI for the EUDAMED requirements - 00:50
EUDAMED Version variations - 02:05
Tips for inputting data – 04:47
UDI Strategy – 10:59
FDA & EU MDR Synchronizing – 16:59
Conclusion – 24:30

Richard Houlihan is the former IT consultant for the European Commission during the creation of EUDAMED, and today he supports medical device manufacturers with their submission through his company, Eirmed.

Dr. Christiana is an Executive Consultant and Business Development Manager at Anteris by Kymanox, and formerly Regional Manger at TUV SUD.