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The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
Session Chair(s)
Michael Ageboh, PhD, RAC
N/A, United States
This presentation will explore the pivotal role of regulatory affairs consulting in the medical device/IVD industry, focusing on how consultants provide strategic value at every stage of product development and commercialization.
Learning Objective : Analyze the strategic role of regulatory affairs consulting in the medical device/IVD industry and its impact on product development and commercialization; Evaluate how specialized regulatory consulting helps manufacturers navigate evolving regulatory requirements while fostering innovation and market competitiveness; Apply practical strategies for partnering with regulatory consultants to achieve regulatory compliance and commercial success.
Speaker(s)
Drug Delivery Device Combination Products - Exploring FDA Expectations from Clinical Investigation to Market Approval
Bryce Whited, PhD, MS
WCI Medtech, United States
Founder and Principal Consultant