Upcoming Webinar

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Validation of FDA-Regulated Systems with AI, ML & LLMs (ChatGPT)

Overview: Life science industries — including pharmaceutical, medical device, biotechnology, ..

Date : 11th September 2025

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 90 Mins

Employee Expense Reimbursements: IRS Rules, Accountable Plans, Per Diems & OBBB Updates

Employee Expense Reimbursements: IRS Rules, Accountable Plans, Per Diems & OBBB Updates

Overview: Employee expense reimbursements may seem straightforward, but when handled incorrect..

Date : 15th September 2025

Time : 1:00 PM Eastern Time / 10:00 AM Pacific Time

Duration : 75 Mins

Edwin Waldbusser


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

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