Edwin Waldbusser
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
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Overview: Human Factors/ Usability is the analysis of how people interact with medical devices...
Date : 23rd September 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning
Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible ..
Date : 25th May 2022
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail
Overview: The US FDA expects that as part of a product development Design Control Program ris..
Date : 27th April 2022
Time : This Event is Over and the Recorded Copy is Available
Duration : 01 Hour 15 Mins
Human Factors/ Usability Studies following ISO 62366 and the new FDA Guidance
Overview: Human Factors/ Usability is the analysis of how people interact with medical devices..
Date : 28th October 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 1 Hour 15 Mins
FDA Regulation of Mobile medical apps and cybersecurity
Overview: This webinar will explain how to determine if your app is a medical device and if it..
Date : 24th August 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 60 Mins
FDA Regulation of Artificial Intelligence/ Machine Learning - What You Need to Know?
Overview: AI/ ML will revolutionize medicine by making diagnosis and treatment more accessibl..
Date : 30th June 2021
Time : This Event is Over and the Recorded Copy is Available
Duration : 60 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 : 1:00 PM Eastern Time/ 10:00 AM Pacific Time
Duration : 75 Mins