Edwin Waldbusser
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
Live Webinars
By: Edwin Waldbusser
Nov. 9, 2026
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Human factors and usability engineering looks at how people interact with medical devices. This 60-minute human factors usability webinar explains how to run rigorous usability studies throughout …
Industry: FDA Compliance Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
By: Edwin Waldbusser
March 16, 2026
FDA QMSR Explained: How the QMSR Replaces the QSR
The FDA Quality Management System Regulation (QMSR) took effect in February 2026, replacing the Quality System Regulation (QSR). This 60-minute FDA QMSR training explains how ISO 13485 has been in…
Industry: FDA Compliance Duration: 60 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
Chronicles
By: Edwin Waldbusser
Recorded Session
Medical Device Hazard analysis following ISO 14971
FDA expects risk management to be part of a medical device design control program and a post-production risk management program to be in place. It recommends ISO 14971 as a guide and accepts it as…
Industry: Medical Devices Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
FDA Regulation of Artificial Intelligence/ Machine Learning
AI and machine learning can make diagnosis and treatment more effective and easier to access, but FDA regulation of AI/ML has not kept pace. FDA has regulated medical software through regulations …
Industry: FDA Compliance Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
21 CFR Part 11 - Compliance for Electronic Records and Signatures
FDA-regulated companies want electronic records for cost and efficiency, while the FDA wants to make sure those records cannot be compromised in ways that could harm patients. 21 CFR Part 11 addre…
Industry: FDA Compliance Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
How to Prepare For and Host a FDA Inspection and Respond to 483's
A company that is ready for an FDA inspection is less likely to receive 483 observations than a disorganized one. This 60-minute webinar covers how to prepare for and host an FDA inspection, and w…
Industry: FDA Compliance Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
Software Validation for the New FDA Inspections
FDA software validation takes more than proving that code works and is free of bugs. This 60-minute webinar explains how to run a software validation program that meets FDA requirements and produc…
Industry: Medical Devices Duration: 60 Minutes
By: Edwin Waldbusser
Recorded Session
21 CFR Part 11 Conformance for Medical Devices
Medical device companies want electronic records for efficiency, while FDA wants to keep those records from being compromised in ways that could harm patients. 21 CFR Part 11 addresses both data s…
Industry: FDA Compliance Duration: 90 Minutes