Upcoming Webinar
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
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
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
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
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
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
Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide
OverviewHazard analysis has always played an important role in medical device safety. Under FDA’s ..
Date : 25th August 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Cybersecurity Following FDA’s 2026 Premarket Guidance
Overview Cybersecurity is now a central part of FDA’s review expectations for many connected, ..
Date : 28th May 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Supplier Selection and Contract Manufacturer Qualification Under FDA QMSR
Overview: FDA’s QMSR places renewed emphasis on the way medical device companies evaluate, se..
Date : 24th March 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
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 : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
FDA’s QMSR is Coming: Practical Readiness for Quality Teams
Overview: With the FDA’s Quality Management System Regulation (QMSR) taking effect in February..
Date : 21st January 2026
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Preparing a FDA 510(k) submission - What to Know in 2025
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 26th June 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
FDA Human Factors Usability Guidance | ISO 62366 & Draft Update Explained
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 29th May 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Minutes
FDA Regulation of Artificial Intelligence/ Machine Learning Software following the 2025 draft Guidance
Overview: AI/ML is rapidly transforming the landscape of medicine, driving unprecedented chan..
Date : March 28, 2025
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Preparing a FDA 510(k) submission - What to Know in 2024
Overview: The FDA 510(k) submission process remains one of the most crucial regulatory pathwa..
Date : 29th October 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024
Overview: In the world of medical device development, the US FDA places a high priority on ri..
Date : 14th August 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Human Factors/ Usability Studies following ISO 62366 , the FDA Guidance and the new FDA Draft Guidance
Overview: Human Factors/Usability studies are essential in ensuring that medical devices are ..
Date : 25th June 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 75 Mins
Medical Device Software Verification and Validation Following FDA 2023 Guidance and ISO 62304
Overview: In the fast-evolving field of medical technology, ensuring the safety and efficacy ..
Date : 28th May 2024
Time : This Event is Over and the Recorded Content is Available
Duration : 60 Mins
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
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
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