An update on the Case for Quality Voluntary Improvement Program was presented during a webinar on May 15, 2019.  The webinar was recorded and the slides for download are now available.   Webinar & Slides

Representatives from CDRH and CMMI provided updates on program progress in year 2, as well as lessons learned from manufacturers, CDRH and CMMI. Mark Rutkiewicz from Innovize, one of the pilot participant sites, joined to share his perspectives on the program as it enters year 2.


  • Kim Kaplan, CMMI Institute
  • Mark Rutkiewicz, Innovize
  • Francisco Vicenty, US FDA Center for Devices and Radiological Health
  • George Zack, Two Harbors Consulting

More information on the Case for Quality or to enroll in the pilot project –