Edwin Waldbusser


FDA Regulation of Artificial Intelligence/ Machine Learning - New FDA Guidance

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

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

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

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

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

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

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

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

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

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?

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

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

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