Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
OVERVIEW
Human Factors/ Usability is the analysis of how people interact
with medical devices. The process of conducting rigorous human factors studies
throughout the medical device design process, integrating it with the medical
device risk analysis and design process, and validating the effectiveness of
the studies will be explained. The various types and methods of use related
hazards and risk 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 which are 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
“use error”. This means that use error is considered by the FDA to be a device
nonconformity because human factors should be considered in the design process.
The burden is on the device designer to create an “idiot proof” product.
Handouts are use specification template, user interface evaluation template, and usability validation control form.
Handouts are use specification template, user interface evaluation template, and usability validation control form.
AREAS COVERED
- User error and use error
- Use related hazards and risk analysis
- User profiles
- Use scenarios
- Step by step human factors program development
- validation
LEARNING OBJECTIVES
Learn the need and basic concept of medical device risk analysis
and how it impacts the medical device design process. Also learn about the FDA
regulations that govern the device design and usability studies.
WHO WILL BENEFIT
- Engineer
- Engineer management
- Quality assurance
- Regulatory
For
more detail please click on this below link:
Email: support@trainingdoyens.com
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
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