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This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the Medical Device Development Tools Program, this program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. -
This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the monitoring essential guidelines for medical devices in the US. She brings to you her professional perspective which stems from her extensive background as an FDA inspector. -
This Meditrial Video Course is designed to help you discover the Early Feasibility Study program and other FDA applicable requirements. -
The Emergency Use Authorization Video Course is designed to help you discover the Emergency Use Authorization and how to apply through this pathway in the U.S. -
This Q-Submission Process Video Course is designed to help you discover the Q-submission process and provide you with an overview on the submission review process, and applicable timelines. -
This 510(k) Submission Video Course is designed to help you discover the 510(k) submission process and provide you with an overview on the submission review process, and applicable timelines. -
This Breakdown Device Designation Video Course is designed to help you discover the Breakthrough Device Designation Program and how to request for the designation of a device in the Breakthrough Program. -
In this Meditrial Video Course you will learn about critical decision points in the decision-making process FDA uses to determine substantial equivalence.
FDA Regulation for Medical DevicesElena Trombettoni2022-12-07T12:04:06+00:00
