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.
Why EBITDA Doesn't Spell Cash Flow and What Does
How to Give Corrective Feedback: The CARE Model - Eliminati…
SOPs - How to Write Them to Satisfy those Inspectors
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Documenting Misconduct that Will Stand Up in Court
Marketing to Medicare or Medicaid Beneficiaries - What You …
Trial Master File (TMF)/eTMF, & FDAs Draft Guidance for Ele…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Project Management for Non-Project Managers - How to commun…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Humane Layoffs: How to Let People Go with Compassion and De…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Female to Female Hostility @Workplace: All you Need to Know
Sunshine Act Reporting - Clarification for Clinical Research
Conquer Toxic People - Learn To Protect Yourself And Get Yo…
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Holiday Stress and Loss: The Art of Stress Resilience in E…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Is Your Culture Working For or Against Your Success? If You…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
Red flags that can render your OSHA Safety Program Complete…
Onboarding is NOT Orientation - How to Improve the New Empl…
The Anti-Kickback Statute: Enforcement and Recent Updates
Eliminate Harmful And Unproductive Drama In The Workplace
3-Hour Virtual Seminar on Chat GPT for Project Management i…
FDA Technology Modernization Action Plan (TMAP) and Impact …
How to Prepare For and Host a FDA Inspection and Respond to…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Managing Toxic & Other Employees Who Have Attitude Issues
Building GMP Excellence: A Guide to Implementing Compliant …
Improving Employee Engagement & Retention Through Stay Inte…
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …