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/cfq/enroll/). CDRH expects the pilot to continue through 2018.
Representatives from CDRH and CMMI provide updates on pilot progress, lessons learned from manufacturers, CDRH and CMMI, and changes made to the program through this quarterly MDICx webinar series. This Q2 webinar features speakers from Baxter and Medtronic speaking to their experience in the pilot. Slides are available here.
