Comprised of the University of Michigan’s MICHR, the University of Pittsburgh’s Office for Investigator-Sponsored IND and IDE Support, and Medical Device Regulatory Solutions LLC, this team brings regulatory expertise and experience from both academia and industry. This core will not only provide comprehensive regulatory support, guidance, and education, but will also assist teams in preparation and filing of regulatory submissions, including Request for Designations, and IND/IDE. In close collaboration with the Commercial Translation/ Future Clinical Adoption team, this team will provide strategic recommendations to navigate the regulatory pathways to position technologies for facile clinical adoption.
- Jeanne Wright, RN, BSN, RAC (University of Michigan)
- Kay Fuller, RAC (MDRS, LLC)
- Shawn Bengston, RQAP-GLP (University of Pittsburgh)
- Denise Deverts, PhD (University of Pittsburgh)