FDA is able to protect and promote public health by enabling the production and commercialization of life-saving medical devices in the U.S. market. 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 four-part webinar series is presented by FDA Case for Quality Program Manager Cisco Vicenty and will present an overview on lessons learned from pilot program participants.
Medical Device Industry Executives
Regulatory Affairs Professionals and Management
Quality Professionals and Management
Clinical Affairs Professionals and Management
R&D Engineers and Management
Greenlight Guru is a modern quality management software platform used by medical device companies in over 600 cities and 35 countries to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based eQMS,
Greenlight Guru is easier to implement, easier to use and simply fits medical device processes out-of-the-box allowing companies to innovate faster and be more efficient. Visit our home page to learn more.
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.