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

• January 8, 2026
• 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

• January 13, 2026
• 60 Minutes
• US$149.00
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This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions.

Edwin Waldbusser

• January 14, 2026
• 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

• January 16, 2026
• 60 Minutes
• US$149.00
• Enroll

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

Edwin Waldbusser

• January 20, 2026
• 60 Minutes
• US$149.00
• Enroll

Human Factors/ Usability is the analysis of how people interact with medical devices.

Edwin Waldbusser

• January 21, 2026
• 60 Minutes
• US$149.00
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Human Factors/ Usability is the analysis of how people interact with medical devices.

Edwin Waldbusser

• January 22, 2026
• 60 Minutes
• US$149.00
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This course will explain the new FDA QMSR that goes into effect in February 2026.

Edwin Waldbusser

• January 27, 2026
• 60 Minutes
• US$149.00
• Enroll

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.

Edwin Waldbusser

• January 28, 2026
• 60 Minutes
• US$149.00
• Enroll