Edwin Waldbusser


Risk Management for ML medical devices following BS/AAMI 34971:2023 and ISO 14971

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

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FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance

FDA Regulation of Artificial Intelligence/ Machine Learning Software following the new draft Guidance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

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

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

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

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