In collaboration with the Center for Devices and Radiological Health (CDRH) a pilot version of the Voluntary Improvement Program (VIP) launched in 2018. The pilot was designed to leverage a proven maturity model, the Capability Maturity Model Integration framework (CMMI), to enable medical device organizations to measure their capability to produce high quality devices and ultimately increase patient safety. The results are then leveraged by the organizations to drive targeted continuous improvement activities throughout their facilities.
In 2019, a new working group was established to guide the development of a concept of operations and strategic plan for the program. To date, more than 86% of the program participants report that the appraisal benefited product quality and more than 90% report a positive experience.
In May of 2021, MDIC’s Case for Quality collaborative community (CFQcc) announced the transition of the VIP from a pilot to a full program. This highly innovative and quality focused program empowers stakeholders across the medical device ecosystem to both improve quality and patient outcomes. In an effort to engage with VIP, the FDA is in the process of developing a complementary permanent program based on the lessons learned from their engagement in the pilot program.
Manufacturers who participate in VIP provide supplementary data to FDA which can help simplify the review of submission activities. FDA will adjust that manufacturer’s engagement activities and change submission requirements.
Enrollment is currently open.
Enrolling your organization:
We encourage you to enroll now as initial early adopter slots will be limited. Contact CMMI if you have questions at email@example.com.
Additional information can also be found in the Federal Register notice.