In this third segment of our FDA: Case for Quality series, the FDA will discuss their focus on quality metrics and indicators versus compliance metrics and indicators, throughout the pilot program.
They will cover the reasoning behind this shift towards quality, the value it has for improving product quality, and how it fits into the future vision of the voluntary pilot program.
Furthermore, they will provide additional details of metrics that are now being shared by participants and how the agency intends to use them.
Finally, in this free 60 minute webinar presented by FDA Case for Quality Program Manager, Cisco Vicenty will provide an overview of what the next steps are for the pilot as we finish 2018 and move into 2019.
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.