My Volunteer Profile

Elijah Wreh is a Regulatory Affairs Manager for Invacare Corporation, a Home Medical Equipment (HME) manufacturer located in Elyria, Ohio. Hands-on regulatory affairs professional with extensive regulatory affairs leadership experience in both government and industry settings. He is also Industry Representative, FDA Advisory Committee Neurological Devices Panel.                             

He is an Adjunct Professor at Case Western Reserve University, Part-Time Lecturer at Northeastern University – College of Professional Studies and guest lecturer at Cleveland State University and the University of Akron.

Mr. Wreh lecture on regulatory aspects of the medical device product commercialization lifecycle from United States; international perspectives and provisions of the US Food and Drug Administration’s (FDA’s) risk-based medical device classification scheme, such as the Premarket Notification [(510(k)], Pre-Market approval (PMA), and Investigational Device Exemption (IDE) submission processes.
He is also a Board Member of CommStar Credit Union in Elyria, OH.