Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

In the ever-evolving landscape of the medical device industry, having a solid regulatory strategy is crucial for success. It goes beyond simply choosing a pathway to market; it involves carefully selecting the best markets and pathways for both your device and your business.

  • Navigating the global market with confidence – developing a comprehensive regulatory strategy
  • How to stay updated on regulatory requirements, engage with regulatory exerts and prioritize quality, safety and compliance throughout the development and commercialization of your medical device
  • How can we develop the right strategy to achieve regulatory compliance efficiently and effectively, and bring safe and innovative medical devises to market

Dina Justice
Vice President, Regulatory Affairs
Terumo Medical Corporation

Dina is currently the Vice President of Regulatory Affairs for Terumo Medical Corporation where she oversees both US and global Regulatory Affairs. Prior to joining Terumo in 2008, Dina spent 17 years at the FDA as a reviewer and later a branch chief in the Division of Cardiovascular Devices. She also spent some time as a Sr. RA consultant prior to joining Terumo.

Dina holds a BS in Biomedical Engineering from The Catholic University of America and a Master of Business Administration from the University of Maryland.