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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.
Expert Speaker
Compliance Specialist
Live Webinars
Chronicles
FDA Compliance
FDA QMSR Explained: How the QMSR Replaces the QSR
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 16 Mar, 2026 (Monday)
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FDA Compliance
Prepare for FDA QMSR Inspections: 483 & Warning Letter Response
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 26 Feb, 2026 (Thursday)
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Medical Devices
Medical Device Hazard analysis following ISO 14971
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 24 Feb, 2026 (Tuesday)
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FDA Compliance
Human Factors Usability Studies Following ISO 62366 and FDA Guidance
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 18 Feb, 2026 (Recorded Session)
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FDA Compliance
FDA Regulation of Artificial Intelligence/ Machine Learning
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 12 Jan, 2026 (Recorded Session)
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FDA Compliance
21 CFR Part 11 - Compliance for Electronic Records and Signatures
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 15 Dec, 2025 (Recorded Session)
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FDA Compliance
How to Prepare For and Host a FDA Inspection and Respond to 483's
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 19 Nov, 2025 (Recorded Session)
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Medical Devices
Software Validation for the New FDA Inspections
Speaker: Edwin Waldbusser
Duration: 60 Minutes Minutes
Date: 14 Feb, 2020 (Recorded Session)
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FDA Compliance
21 CFR Part 11 Conformance for Medical Devices
Speaker: Edwin Waldbusser
Duration: 90 Minutes Minutes
Date: 27 Jun, 2019 (Recorded Session)
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