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

• April 23, 2024
• 60 Minutes
• US$149.00
• Enroll

This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process.

Edwin Waldbusser

• April 24, 2024
• 60 Minutes
• US$149.00
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This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. ISO 13485 has almost identical requirements. Such a program will also help to get projects completed on time and within budget.

Edwin Waldbusser

• April 26, 2024
• 60 Minutes
• US$149.00
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"Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO"

Edwin Waldbusser

• April 30, 2024
• 60 Minutes
• US$149.00
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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

• May 9, 2024
• 60 Minutes
• US$149.00
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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

• May 15, 2024
• 60 Minutes
• US$149.00
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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

• May 21, 2024
• 60 Minutes
• US$149.00
• Enroll

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

Edwin Waldbusser

• May 23, 2024
• 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

• May 29, 2024
• 60 Minutes
• US$149.00
• Enroll