Webinar Information


Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance


Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance, Aurora, Colorado, United States
Webinar Title
Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance
Event Type
Webinar
Webinar Date
12-02-2019
Last Date for Applying
12-02-2019
Location
Aurora, Colorado, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Training Doyens
Organizing/Related Departments
Life Science
Organization Type
Organization/Company
Webinar Category
Both (Technical & Non Technical)
Webinar Level
All (State/Province/Region, National & International)
Related Industries

Engineering

Education/Teaching/Training/Development

Biotechnology

Medical/Healthcare/Hospital

Location
Aurora, Colorado, United States

OVERVIEW

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 medical device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors/usability 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 so designed 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 device nonconformity because human factors/ usability should be considered in the design process. The burden is on the device designer to follow usability studies, perform medical device risk analysis and create an “idiot proof” product.

Handouts are use specification template, user interface evaluation template, and usability validation control form

AREAS COVERED

  • Difference between 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 about use related hazards and risk analysis in medical devices and how to create a device that complies with the FDA guidance. Know how to assess human factors/usability in the design process and maintain compliance with ISO 62366.

WHO WILL BENEFIT

  • Engineer
  • Engineer management
  • Quality assurance
  • regulatory

 

For more detail please click on this below link:

https://bit.ly/2sMbHzm

Email: [email protected]

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

 

Others Details

Know about human factors/usability in medical devices and how to perform medical device risk analysis. Also know what the FDA guidance says about the design process and how to comply with ISO 62366.

Registration Fees
Not Mention
Registration Ways
Email
Phone
Website
Other
Address/Venue
Training Doyens 26468 E Walker Dr,Aurora, Colorado  Pin/Zip Code : 80016-6104
Landmark
CO
Official Email ID
Contact
Training Doyens

Training Doyens 26468 E Walker Dr,Aurora, Colorado

[email protected]

   +1-720-996-1616