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

Date :Tuesday February 12th, 2019

Location :Training Doyens 26468 E Walker Dr
26468 E Walker Dr, Aurora, Colorado 80016
80016-6104 Aurora, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

 

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: support@trainingdoyens.com

Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

 

 

 


Location

Map and directions
Conference address :
Training Doyens 26468 E Walker Dr
26468 E Walker Dr, Aurora, Colorado 80016
80016-6104 Aurora
United States
tel : +1-720-996-1616
Map and directions

Further information

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Details

Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance Pharmacy - Medicine
human factors usability, medical device risk analysis, iso 62366 training program
Professionals
20 1 --
English

Other

For more information on Live Webinar on Human Factors/ Usability Studies Following ISO 62366 and the New FDA Guidance, plsase contactr Training Doyens

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