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.
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
New EEOC Report: Workplace Harassment Prevention Not Workin…
Human Error Reduction Techniques for Floor Supervisors
21 CFR Part 11 - Compliance for Electronic Records and Sign…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Transforming Change and Conflict into Diverse-Inclusive-Col…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Navigating 2025 Employment Laws: What Every Employer Needs …
Managing Difficult Employee Conversations
ChatGPT and Project Management: Leveraging AI for Project M…
Future Of Forecasting And Budgeting With Rolling Forecast
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Internal Controls in Accounts Payable
The FMLA - An Employer's Guide to Compliance and Employee A…
Excel Power Skills: Master Functions, Formulas, and Macros …
Develop People Intelligence: Is Your Communication Style as…
The Impact of Artificial Intelligence on Your Workforce
AI in Everyday Work – help with Microsoft products
How to Document Employee Discussions and Why it is Important
Construction Lending And Real Credit Administration: Evalua…
The Anti-Kickback Statute: Enforcement and Recent Updates
Navigating FDA Inspections: From SOP to 483
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on DeepSeek R1 for Business and Mark…
Risk Analysis in the Medical Device Design Process
Introduction to Microsoft Power BI Dashboards
How To Get Control of Your Day, Life & Career - Time Manage…
AI Across the Business: Practical Use Cases for Founders an…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Female to Female Hostility @Workplace: All you Need to Know
Writing Effective 483 and Warning Letter Responses
FDA Recommendations for Artificial Intelligence/Machine Lea…
Language is Code - Intro to AI - Generative AI - ChatGPT an…
Understanding EBITDA – Definition, Formula & Calculation