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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. -
This Meditrial Video Course is designed to help you discover the Early Feasibility Study program and other FDA applicable requirements. -
LEARN FOR FREE In the world today we need digital health. We will discuss what is the digital health revolution and in what way has Covid acted as the catalyzer. We will then get into what are the tools and technologies that are already out there today. -
LEARN FOR FREE The Digital Health landscape is rapidly expanding and innovating. In this webinar Peter Fitzgerald delivers an informative and interesting presentation of digital health in the COVID Age and forward. -
The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring during the clinical investigation and Regulatory comparison: MDD vs MDR. -
This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination).
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
