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Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations
Session Chair(s)
Shayesteh Fürst-Ladani, MBA, MS
CEO, SFL Regulatory Affairs & Scientific Communication, Switzerland
Challenges in the Current Regulatory Landscape Considering FDA and MDR Expectations
Speaker(s)
Niall MacAleenan
Medical Device Lead/Clinical Assessment and Policy Manager, Health Products Regulatory Authority (HPRA), Ireland
A European Regulatory Authority Perspective on the New EU Device Regulations
Karin Schulze, DRSC
Head Medical Devices, SFL Regulatory Affairs & Scientific Communication, Switzerland
How MDR Impacts Medical Device Manufacturer?
Murray Malin, MD, MBA
Medical Director, Abbvie, United States
Industry Preparation to Comply with the FDA and MDR/IVDR Regulatory Requirements
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