FDA's Case For Quality: What, Why, And How? Changing The Regulatory Paradigm

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 free 90 minute webinar is presented by FDA Case for Quality Program Manager Cisco Vicenty and will present an overview on lessons learned from pilot program participants. 

Watch the webinar

fda_case_for_quality (1)
Specifically, this webinar will cover:
  • 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
Who Should Attend?
  • Medical Device Executives
  • Regulatory Affairs Professionals and Management
  • Quality Professionals and Management
  • Clinical Affairs Professionals and Management 
  • R&D Engineers and Management
Register Now  

Hosted by

Presenter: Francisco Vicenty

Case for Quality Program Manager, FDA

Jon Speer
Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


In keeping with our mission, the Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

We seek to continually improve our effectiveness in fulfilling our mission by planning strategically and regularly monitoring our progress..


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

Featured In