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Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance
Overview: AI/ML is rapidly transforming the landscape of medicine, driving unprecedented chan..
Date : March 28, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance
Overview: Artificial Intelligence (AI) and Machine Learning (ML) are fast becoming game-change..
Date : 24th October 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Software Validation Meeting FDA Regulations
Overview: Testing software to prove that it works and has no bugs is not sufficient to obtain ..
Date : 25th October 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA’s Q-Submission Program for Medical Devices, Software-in-a-Medical Device Products & SaMD with Considerations for Using AI & ChatGPT
Overview: The U.S. Food and Drug Administration (FDA) has taken a major step toward modernizi..
Date : 22nd October 2025
Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time
Duration : 90 Mins