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Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations

Track:
A New Era for Medical Devices and Diagnostics. How Is The Impact?

Day & Time:
April 18, 4:00PM - 5:30PM (Central Europe Standard Time)

Session Number:
S0703

Type:
Session

Title:
Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations

Chair(s):
Shayesteh Fuerst-Ladani, MBA, MS
Managing Director and Founder
SFL Regulatory Affairs & Scientific Communication GmbH, Switzerland

Description:
Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations

Presentation(s) & Speaker(s):
A European Regulatory Authority Perspective on the New EU Device Regulations
Niall MacAleenan
Medical Device Lead/Clinical Assessment and Policy Manager
Health Products Regulatory Authority (HPRA), Ireland

How MDR Impacts Medical Device Manufacturer?
Karin Schulze
Managing Director
SFL Regulatory Affairs & Scientific Communication, Switzerland

Industry Preparation to Comply with the FDA and MDR/IVDR Regulatory Requirements
Murray Malin, MD, MBA
Medical Director
Abbvie, United States