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#308: The Role of Medical Device/IVD Regulatory Consulting in Navigating Complex Global Regulatory Pathways
Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-615-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Michael Ageboh, PhD, RAC

Speaker

Drug Delivery Device Combination Products - Exploring FDA Expectations from Clinical Investigation to Market Approval
Bryce Whited, PhD, MS


Speakers
MA

Michael Ageboh

Senior Manager, MedTech Services, Pharmalex / Cencora, United States
Michael Ageboh is a regulatory affairs professional with extensive experience within the MedTech industry. He has been involved in the end-to-end process of getting new products to market and maintaining products post market launch. He has worked for small, medium and large companies... Read More →
BW

Bryce Whited

Founder and Principal Consultant, WCI Medtech, United States
Bryce Whited, Ph.D. is the Founder and Principal Consultant at WCI MedTech, a consulting firm dedicated to providing medical device and pharma / biologics clients with expert regulatory affairs services for product development, market approval and post-market compliance. Bryce has... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
147AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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