MDICx: Update on the Case for Quality Voluntary Improvement Program (CFQ VIP)
August 27, 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. Vadim Kastin from Biosense Webster will share his experience as a participant in a multi-site appraisal in the Case for Quality Voluntary Improvement Program.
- Vadim Kastin, Head, WW Quality & Compliance, Biosense Webster, Part of the Johnson & Johnson family of companies
- Kim Kaplan, CMMI Institute
- Francisco Vicenty, US FDA Center for Devices and Radiological Health
- George Zack, Two Harbors Consulting