The approach to quality in the Medical Device and Pharmaceutical Industry has typically been focused on compliance rather than quality and often included an adversarial relationship between regulators and the industry. This approach has often resulted in a failure to adopt new approaches to quality and new technologies for fear of creating a compliance risk. It has also created a practice of segregating processes into “inside the quality system” and “outside the quality system”. This has contributed to our industry falling decades behind in our approach to quality and resulted in capabilities which are significantly lower than other industries. The FDA is partnering with industry to implement CMMI in order to reverse this trend and bring our industry into the 21st century. This presentation outlines one company’s approach to this new paradigm and the value proposition associated with this change.