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.
The Importance of the first 5 seconds when presenting
Project Management for administrative professionals
How to Reduce Human Error in a GMP Manufacturing Floor
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Launch Your Career: The Ultimate Guide for Emerging Profess…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Managing Toxic & Other Employees Who Have Attitude Issues
Data Integrity – In compliance with CSA, 21 CFR Part 11, Sa…
Effectively Handle Toxic People for Better Productivity and…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Employee Handbooks: 2025 Critical Issues
Better Business Writing-How to Write Right
The five qualities every successful leader must develop
How to Lead and Manage a Narcissistic Employee
Use of AI and GPT for Finance Professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Analytical Method Validation Under Good Laboratory Practic…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Excel What-If-Analysis Decision-Making Tools
How to Write Contracts for Procurement Professionals
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People: At Work & In Life
Excel - Reporting Simplified - Learn Pivot Tables from Scra…
Retention Starts Here: Stop Losing Your Critical Talent and…
Turning Workplace Conflict into Positive Connection
Project Management for Non-Project Managers - How to commun…
The Business Case for LGBTQIA+ Inclusion in the Workplace: …
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
AI-Powered Change Leadership Operationalizing AI: Practical…
AI and Human Resources: The Great Opportunity!
Cyber Security Incident Response Team Training Program
Transforming Anger And Conflict Into Collaborative Problem …
The Courage to Speak: Overcoming Fear and Owning the Room
Finance & Accounting 101 Simplified
6-Hour Virtual Boot Camp on Microsoft Power BI