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 design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
The FDA will only approve devices designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “user error,” which means that it’s how the product is used and not a human error that is considered by the FDA to be a device nonconformity. As a result, human factors should be considered in the design process, and the burden is now on the device designer to create an “idiot-proof” product.
Human Factors Usability Testing is the analysis of how people interact with medical devices. This session will explain 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. The various types and methods of human factors analysis will also be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
The FDA will only approve devices designed so that it is practically impossible for people to accidentally harm themselves even if they use the device improperly. The FDA has replaced the term “user error” with “user error,” which means that it’s how the product is used and not a human error that is considered by the FDA to be a device nonconformity. As a result, human factors should be considered in the design process, and the burden is now on the device designer to create an “idiot-proof” product.
Human Factors Usability Testing is the analysis of how people interact with medical devices. This session will explain 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. The various types and methods of human factors analysis will also be explained. This process conforms to the new ISO 62366 standard and the new FDA Guidance document.
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.
6-Hour Virtual Boot Camp on Microsoft Power BI
2-Hour Virtual Seminar on Empowering Presentations with Pow…
Motivated to Stay: Effective and Best Practice Retention Me…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
The Anti-Kickback Statute: Enforcement and Recent Updates
Mindful Communication:The Key to Meaningful Conversations i…
Managing Toxic & Other Employees Who Have Attitude Issues
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Employee Handbooks: 2025 Critical Issues
Accounting For Non Accountants : Debit, Credits And Financi…
ChatGPT and Project Management: Leveraging AI for Project M…
50+ new Excel features so far this decade
2025 EEOC & Employers: Investigating Claims of Harassment …
Why EBITDA Doesn't Spell Cash Flow and What Does?
Retaining Talent in the Age of Employee Shortages
Succession Planning Simplified: Fast-track Your Future Lead…
Workplace Compliance in 2025: New Laws, Big Changes, and Wh…
How to Write Contracts for Procurement Professionals
Leverage AI & ChatGPT for Talent Acquisition: Best Practice…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Female to Female Hostility @Workplace: All you Need to Know
Leadership: Strategic Planning and Decision Making