Medical Devices – moving from the mind to the marketplace

Doors open at 5:00. pizza out at 5:30, presentation starts at 6:00

This Tech on Tap presentation will focus on the medical device start-up potential surrounding the IU Medical School in Evansville and the community resources in place to assist medical device development. Additionally, the talk will summarize the process for medical device start-ups seeking market approval for new technologies and the associated regulatory challenges.  

Dr. Randy Scherer is a Sr. Project Manager for DEKRA Certification Inc. DEKRA Certification is a leading Notified Body working with Medical Device Manufacturers seeking to get their products to different markets including the US and EU. Dr. Scherer’s primary role is to assess and review client’s medical device technical files for regulatory requirements and to audit manufacturers Quality Management Systems ensuring compliance to the Medical Device Directives/ U.S. C.F.R./Canadian Medical Device Directives. Dr. Scherer manages a portfolio of global medical device companies and serves as the nanomaterial and biocompatibility subject matter expert for DEKRA.

Dr. Scherer holds a bachelor’s degree in Biochemistry from the University of Evansville and his doctoral degree in Interdisciplinary Materials Science and Engineering from Vanderbilt University. His research experience includes multifunctional nanomaterials for targeted drug delivery, immune responsive biomaterials, magenetic nanoparticles, and minimally invasive cardiovascular medical devices.