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Exploring EUDAMED Requirements for EU MDR, with Richard Houlihan and Christiana Hofmann
Manage episode 372936426 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 informative episode of The Factor, we sit down with industry experts Dr. Christiana Hofmann and Richard Houlihan to discuss critical aspects of EUDAMED, the European Union's Medical Device Database, and the EU MDR's implementation journey. The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746). EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU).
Our experts discuss the challenges and opportunities brought about by the EUDAMED requirements, and explore how the delay in MDR implementation impacted the industry and why the EUDAMED platform holds promise for ensuring safe devices and empowering patients and healthcare professionals with critical information.
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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