FDA’s Case for Quality initiative has clearly established that good compliance does not necessarily equal good patient outcomes, and vice versa. In this spirit, the FDA partnered with the Medical Device Innovation Consortium (MDIC) to launch a pilot program designed to better align FDA and industry around improving product quality and patient outcomes. This pilot program leverages CMMI’s capability model. CMMI’s model is very new to the medical device industry; however, it is widely used in other industries with a track record of improving product quality on top of other business benefits. The CMMI model appraises an organization’s capabilities across a breadth of established practice areas, as compared to a traditional inspection or audit method such as QSIT or MDSAP, which interrogates an organization’s compliance with regulations and standards. Because the CMMI model is so different from anything the medical device industry has experienced, participating companies need to prepare their site leadership and people to engage in a very different way in this process. This is far from trivial, but if this pilot program’s goals are realized, it will be well worth the effort! Come hear about the experience of one site in a large medical device company that is participating in the pilot, and recently completed its first CMMI appraisal.