Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA's medical devices center is a focus on quality. The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. This program allows the FDA to recognize device manufacturers that are capable of consistently producing high-quality devices and continuously improving. Greenlight Guru is partnering with FDA CDRH to help spread the word and promote the Case for Quality initiative and its benefits to the medical device industry. This is the first of four presentations, learn about the others at greenlight.guru. Key points in this presentation: -Learn about CfQ – What it is, why we are doing it, and how we are engaging -Introduce pilot programs – Provide summary detail on various pilots at CDRH and associated with CfQ -Regulatory paradigm – How is FDA rethinking the regulatory engagement Watch this presentation, by Franciso Vicenty, the Case for Quality Manager of the FDA, here: https://www.greenlight.guru/webinar/fda-case-for-quality