Edwin Waldbusser
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance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
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 25th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971
Overview: FDA has always prioritized the risk management of medical devices, adhering to its ..
Date : 27th February 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Medical Device Cybersecurity following September 2023 FDA Premarket Guidance
Overview: This webinar will cover FDA's evolving position on medical device cybersecurity. The..
Date : 29th November 2023
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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance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
RISK MANAGEMENT FOR ML MEDICAL DEVICES FOLLOWING BS/AAMI 34971 AND ISO 14971
Overview:In the field of medical technology, the integration of Machine Learning (ML) within medic..
Date : 28th August 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Cybersecurity following 2022 FDA Premarket Guidance
Overview: In this informative webinar, we delve into the critical field of medical device cyb..
Date : 20th June 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance
Overview:Explore how AI/ML is transforming medicine by making diagnosis and treatment more accessibl..
Date : 27th April 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Engineering Change Control in Medical Device Environment
Overview:Change control focuses on managing changes throughout a product’s life cycle as a part of ..
Date : 30th March 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
How to get a 510(k) for a Machine Learning Product - Understanding the Regulatory Requirements
Overview:FDA clears the final validated version of software and requires a new 510(k) submission i..
Date : 22nd February 2023
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Preparing a FDA 510(k) submission - What to Know
Level:- Beginner to Intermediate Overview: Preparing a submission to get FDA approval for ..
Date : 22nd November 2022
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