Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser

• June 25, 2025
• 60 Minutes
• US$149.00
• Enroll

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security.

Edwin Waldbusser

• June 30, 2025
• 60 Minutes
• US$149.00
• Enroll

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser

• July 2, 2025
• 60 Minutes
• US$149.00
• Enroll

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Edwin Waldbusser

• July 7, 2025
• 60 Minutes
• US$149.00
• Enroll

This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product.

Edwin Waldbusser

• July 10, 2025
• 60 Minutes
• US$149.00
• Enroll

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Edwin Waldbusser

• July 17, 2025
• 60 Minutes
• US$149.00
• Enroll

Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained.

Edwin Waldbusser

• July 24, 2025
• 60 Minutes
• US$149.00
• Enroll