Our Team

Tracy Eberly is a regulatory compliance leader with over 30 years of experience in the medical device industry, 
specializing in Regulatory Affairs, Quality Systems, and global market approvals. He has supported both 
emerging startups and leading multinational manufacturers in navigating complex regulatory pathways across the 
full product lifecycle.

Tracy has successfully led regulatory strategies and obtained approvals for Class I, II, and III medical devices in 
the United States, European Union, and more than a dozen international markets worldwide. His technical 
expertise spans a broad range of technologies, including RF ablation catheters, steroid-eluting leads, lasers, and 
implantable medical devices. His global experience includes regulatory submissions across markets such as 
China, Japan, Brazil, South Korea, Australia, the Middle East, Africa, and Latin America.

Throughout his career, Tracy has held consulting and leadership roles supporting major organizations including 
Johnson & Johnson, Abbott, Medtronic, Boston Scientific, St. Jude Medical, GE Healthcare, Fresenius Medical 
Care, and other global medical device manufacturers. He brings a strong cross-functional perspective, informed 
by prior roles in regulatory affairs, quality systems, engineering, and product development.

Tracy holds a Bachelor of Science degree from the University of Minnesota and is based in Edina, Minnesota.