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Navigating the Challenges of UDI Compliance in Europe's Evolving Regulatory Landscape (Part 2 with Dr. Christiana Hofmann and Richard Houlihan)
Manage episode 374371785 series 3428201
Το περιεχόμενο παρέχεται από το The Factor, a global medical device podcast. Όλο το περιεχόμενο podcast, συμπεριλαμβανομένων των επεισοδίων, των γραφικών και των περιγραφών podcast, μεταφορτώνεται και παρέχεται απευθείας από τον The Factor, a global medical device podcast ή τον συνεργάτη της πλατφόρμας podcast. Εάν πιστεύετε ότι κάποιος χρησιμοποιεί το έργο σας που προστατεύεται από πνευματικά δικαιώματα χωρίς την άδειά σας, μπορείτε να ακολουθήσετε τη διαδικασία που περιγράφεται εδώ https://el.player.fm/legal.
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.
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.
About the Factor:
The Factor, your trusted podcast for the life sciences industry. Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.
About Kymanox:
Kymanox has proven, collaborative, end-to-end solutions that help bring life science products to the market – and keep them there. We are a global professional services organization that supports comprehensive drug development with integrated science, engineering, compliance (e.g., QA/RA), and technical project management. Our work across small and large molecules, medical devices, and combination products affords us a wholly unique advantage. With our diverse team of experts, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s life cycle – from early development to post-market – with optimized safety, quality, efficacy, and accessibility. We strive to advance life science innovation through insightful solutions and collaboration…because patients deserve better. Kymanox was founded in 2004 and is headquartered in Morrisville, North Carolina USA. Kymanox is backed by WestView Capital Partners, a Boston-based growth equity firm. For more information, visit https://www.kymanox.com/.
The Factor is edited and produced by Earfluence.
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