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Edwin Waldbusser

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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.

Live Webinar

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By: Edwin Waldbusser

Jan. 20, 2022

Human Factors Usability Studies Following ISO 62366 and FDA Guidance

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the …

Industry: FDA Compliance   Duration: 60 Minutes   Time: 10:00 AM PST | 01:00 PM EST

Recorded Session

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By: Edwin Waldbusser

Recorded Session

21 CFR Part 11 Conformance for Medical Devices

This Webinar will explain what 21 CFR Part 11 is? Why it is important for FDA regulated companies? and how conformance to Part 11 differs from just having good IT security? Procedures for controll…

Industry: FDA Compliance   Duration: 90 Minutes  

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By: Edwin Waldbusser

Recorded Session

Software Validation for the New FDA Inspections

The imperative aspect of Software Validation is the backbone of the software industry that deals with software authenticity, efficiency, and removes any invalidated bug that might risk the…

Industry: Medical Devices   Duration: 60 Minutes