Navigating the EU MDR as a Medical Device Manufacturer

Presented by

Scott Ehlert (AtriCure); Sandra Rodriguez (Axendia); Fiona Maini

About this talk

The European Union Medical Device Regulation (EU MDR) governs the production, distribution of medical devices in Europe, and compliance is mandatory for companies who wish to sell medical devices in European markets. These regulations have significant implications across the medical device product lifecycle including product design & development, commercialization and post-market surveillance. From a business perspective, medical device & technology (or MedTech) companies may face challenges such as resource constraints, a lack of familiarity with the regulation, and the need to update older products to comply with the EU MDR. On the technological front, medical device manufacturers may struggle with disjointed and siloed systems, particularly in light of the EU MDR's requirement for comprehensive, data-intensive total product lifecycle management.

Related topics:

More from this channel

Upcoming talks (0)
On-demand talks (11)
Subscribers (333)
Dassault Systèmes is a science-based company providing technology solutions for innovation. We draw on various branches of science – mathematics, biology, chemistry, physics, geology – to break down silos of knowledge and find the most innovative, sustainable solutions for the future. Subscribe to this channel featuring content for those who develop and bring BioPharma and Medical Device therapies to market for the advancement of human health.