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This Meditrial Video Course is designed to help you discover the FDA De Novo Classification Pathway and intended to provide De Novo requesters with transparency regarding the process of submission De Novo Classification request. -
In the Premarket Approval course we will provide regulatory information on the Premarket Approval process. -
The Safer Technology Program Video Course is designed to help you discover STeP and how to navigate program principles and structure. -
The Clinical Laboratory Improvement Amendments Video Course is designed to help you discover the CLIA and how to determine and apply for CLIA waiver or Dual 510(k) by application studies. -
Welcome to the Meditrial training on FDA IVD Regulation. In this training, you will learn what an IVDs are and the factors needed for regulation and classification. -
In this Meditrial Video Course you will learn about critical decision points in the decision-making process FDA uses to determine substantial equivalence. -
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. -
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 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. -
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.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
