Originally Aired - Thursday, February 9 • 2:30 PM - 3:15 PM Pacific Time (US & Canada); Tijuana
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Location: MedTech Theater
Title: Implementing EU Regulations: Challenges & Lessons Learned
Event Type: Expo Education
Pass Type: Expo Pass , Expo + Medical Battery Conference 2-Day Pass, Expo + Medical Workshops Pass, Expo + Medical Battery Conference 2-Day + Medical Workshops Pass, 3-Day Pass, 3-Day + Medical Battery Conference 2-Day Pass, 3-Day + Medical Workshops Pass, 3-Day + Medical Battery Conference 2-Day + Medical Workshops Pass, 2 Day-Pass, 2-Day + Medical Battery Conference 2-Day Pass, 2-Day + Medical Workshops Pass, 2-Day + Medical Battery Conference 2-Day + Medical Workshops Pass, Medical Battery 2-Day Pass , Medical Battery 2-Day Pass , Medical Battery 2-Day+Workshops Pass
Our presentation will discuss the challenges facing the Notified Body system, the potential difficult decisions that medical device manufacturers will have to make when they determine their regulatory strategy, the practical reality of changing notified bodies and/or working with multiple notified bodies (e.g., in case of M&A of a startup), specific new areas in medical device software including AI/ML, and the overall impact to the EU healthcare system. Considering the new deadlines from the EU, we will also review how they will impact medical device manufacturers and what opportunities do these extensions lend.
