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Part 2 - NEW Nacha Operating Rules Changes for 2026 and Beyond: IAT Entries, ACH Contact Registry & R90

Part 2 - NEW Nacha Operating Rules Changes for 2026 and Beyond: IAT Entries, ACH Contact Registry & R90

Overview: Each participant in the ACH Network is required to follow the Nacha Operating Rules ..

Date : 18th February 2026

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

Duration : 120 Mins

Overtime, Exemptions & Salary Thresholds under FLSA (2026)

Overtime, Exemptions & Salary Thresholds under FLSA (2026)

Overview: In 2026, overtime and exemption decisions have become a moving target for payroll a..

Date : 18th February 2026

Time : 2:00 PM Eastern Time / 11:00 AM Pacific Time

Duration : 60 Mins

ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration

ISO 13485:2016 Utilizing Principles of Lean Documents and Lean Configuration

Overview: Medical device and life science organizations are expected to maintain a Quality Ma..

Date : 20th February 2026

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

Duration : 90 Mins

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..

Date : 23rd February 2026

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

Duration : 60 Mins

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

Data Integrity and Privacy - Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR in 2026

Overview: In 2026, data integrity and privacy risks don’t sit in one department—they show up ..

Date : 24th February 2026

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

Duration : 90 Mins

Edwin Waldbusser


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

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Overview: FDA inspections under the new QMSR can look and feel different—not just in what inv..

Date : 23rd February 2026

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

Duration : 60 Mins

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