Upcoming Webinar

Employee Terminations: Avoiding Costly Mistakes Before, During and After Dismissal

Employee Terminations: Avoiding Costly Mistakes Before, During and After Dismissal

Overview: An employee termination may take only a few minutes, but the consequences of a poor..

Date : 05th November 2026

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

Duration : 75 Mins

The 6 Most Common FDA Software Validation Failures and How to Prevent Them

The 6 Most Common FDA Software Validation Failures and How to Prevent Them

Overview: One of the most concerning findings during an FDA inspection is discovering that an ..

Date : 10th November 2026

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

Duration : 75 Mins

FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit

FDA Biocompatibility in 2026: What to Test, What to Justify, and What to Submit

Overview A medical device can undergo extensive biocompatibility testing and still encounter ..

Date : 16th November 2026

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

Duration : 120 Mins

Employee Attendance and Medical Restrictions: When to Accommodate, Discipline or Terminate

Employee Attendance and Medical Restrictions: When to Accommodate, Discipline or Terminate

Overview: An employee has accumulated enough attendance points for a final warning. The super..

Date : 17th November 2026

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

Duration : 120 Mins

Paid Leave and PTO Compliance in 2027: State Changes, Payroll Taxes and Policy Updates

Paid Leave and PTO Compliance in 2027: State Changes, Payroll Taxes and Policy Updates

Overview An employer can offer more PTO than the law requires and still have a paid leave com..

Date : 18th November 2026

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

Duration : 90 Mins

2026 Form W-2 Update: Overtime, Tips, Reconciliation and Year-End Reporting

2026 Form W-2 Update: Overtime, Tips, Reconciliation and Year-End Reporting

Overview Preparing W-2s has always required careful year-end review, but 2026 brings new repor..

Date : 19th November 2026

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

Duration : 60 Mins

Edwin Waldbusser


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

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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