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.
WHY SHOULD YOU ATTEND?
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.
AREA COVERED
- The need for understanding and optimizing how people use and interact with technology
- Definitions: Use scenario, task, critical task
- Latest FDA Guidance on applying human factors and usability engineering to medical devices
- Usability plan
- Use specification
- Usability hazard analysis
- Use-related hazards
- User interface specification
- User interface evaluation plan
- Preliminary analysis and evaluations
- Evaluation methods
- Analytical methods
- Empirical methods
- Verification and validation
- Human factors report
LEARNING OBJECTIVES
- User error versus use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step-by-step human factors program development
- Validation
- Use specification template
- User interface evaluation template
- Usability validation control matrix form
WHO WILL BENEFIT?
- Development Engineers
- Production Management
- QA/QC Personnel
- Software Developers
- Usability engineers
- Risk managers
- Design Engineering Managers
- Engineer
- Engineer Management
- Quality assurance
- Regulatory Professionals
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 need for understanding and optimizing how people use and interact with technology
- Definitions: Use scenario, task, critical task
- Latest FDA Guidance on applying human factors and usability engineering to medical devices
- Usability plan
- Use specification
- Usability hazard analysis
- Use-related hazards
- User interface specification
- User interface evaluation plan
- Preliminary analysis and evaluations
- Evaluation methods
- Analytical methods
- Empirical methods
- Verification and validation
- Human factors report
- User error versus use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step-by-step human factors program development
- Validation
- Use specification template
- User interface evaluation template
- Usability validation control matrix form
- Development Engineers
- Production Management
- QA/QC Personnel
- Software Developers
- Usability engineers
- Risk managers
- Design Engineering Managers
- Engineer
- Engineer Management
- Quality assurance
- Regulatory Professionals
Speaker Profile
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.
Upcoming Webinars
Understanding the Math of HR… So You Can Show How HR Impact…
Sunshine Act Reporting - Clarification for Clinical Research
I-9 Audits: Strengthening Your Immigration Compliance Strat…
How to Address ISO's New Climate Change Requirements
Re-imagine Finance & Accounting Made Simple. Three Webinars…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Managing Toxic & Other Employees Who Have Attitude Issues
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Onboarding New Hires: Leverage the Potential of Artificial …
Do's and Don'ts of Giving Effective Feedback for Performanc…
How to Document Employee Discussions and Why it is Important
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
Project Management for HR, Administrative Professionals, an…
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Best Practices for Working With Vendors and Suppliers
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Accounting For Non Accountants : Debit, Credits And Financi…
Independent Contractor vs. Employee New Rule Issued by The …
Principles & Practices for the Cybersecurity of Legacy Medi…
The Top Ten Excel Functions Everyone Should Know
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Clinical Trial Systems: The Trial Master File (TMF) and Ele…
Dealing With Difficult People In Life & Work
Fair Lending in Q2 2024: new regulations, examinations, and…
Improving Employee Engagement & Retention Through Stay Inte…
Coming Soon - New Minimum Salary Levels for Exempt Employee…
FDA Regulation of Artificial Intelligence/ Machine Learning
Beyond ‘Illegal’ Interview Questions: What Recruiters & Hir…
Form 1099 Update 2024: Latest Forms, Rules and Reporting Re…
Building Fair Chance Hiring Policies in 2024
Emotional Intelligence: Mastering the Emotions of Great Lea…
Writing Techniques for Auditors and Risk Management Profess…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
Third-Party Relationships: Risk Management: What All Bankin…
HR 101 - Bootcamp Basics for New Human Resource Professiona…