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:To err is human. That’s where we come in. The Factor is your trusted podcast for the global medical market. We are highlighting various topics and viewpoints within our industry. Our goal is to create dialogue that promotes best practices in creating safer medical products for the end user.  It is brought to you by Agilis by Kymanox, and is produced by Earfluence.

Id. d’épisode : 1000623129304

GUID : ceaae3ec-1987-4460-8e24-74e1e1743935

Date de publication : 2/8/2023 à 06:00:00