MDICx: Update on the Case for Quality Voluntary Improvement Program (CFQ VIP)
May 15, 2019, 1 p.m. ET/ 12 p.m. CT/ 10 a.m. PT
In 2017, CDRH, in partnership with the Medical Device Innovation Consortium and the CMMI Institute, launched a pilot project designed to incentivize medical device manufacturers to demonstrate mature quality practices by reducing certain regulatory requirements for those who demonstrate quality maturity (https://live-mdic.pantheonsite.io/project/cdrh-quality-pilot/). With the success of the pilot, MDIC is working together with FDA and CMMI to formalize this pilot into a full program, now known as the Case for Quality Voluntary Improvement Program
Representatives from CDRH and CMMI will provide 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, will join us to share his perspectives on the program as it enters year 2.
Speakers:
- Kim Kaplan, CMMI Institute
- Mark Rutkiewicz, Innovize
- Francisco Vicenty, US FDA Center for Devices and Radiological Health
- George Zack, Two Harbors Consulting
