The FDA initiated the Case for Quality (CfQ) in 2011 after an in-depth review of device quality data and feedback from industry stakeholders. The analysis showed that firms that manage risks by driving quality organization-wide are more productive. They have fewer complaints and investigations per batch. This is accomplished with smaller quality teams with lower quality-related costs than their competitors. The Case for Quality has three core components; focus on quality, enhanced data transparency and stakeholder engagement. This white paper explores the FDA’s CfQ in detail. It will describe the impact of cost of quality (CoQ), and the cost of poor quality (CoPQ). It will explain the benefits of implementing a quality focused approach methodology and outline steps that medical device manufacturers can take to gain benefits from investing in quality.