HUMAN FACTORS & USABILITY SOP GROUP

HUMAN FACTORS & USABILITY SOP GROUP

This SOP group will allow you to create a compliant program following ISO62366 and the 2016 FDA guidance.


Display per page
Sort by

This group of SOP's will allow you to create a compliant program following  ISO 62366 and the 2016 FDA Guidance.

Select this item to order all titles below at a reduced price.

.

$900.00

This SOP defines the Human Factors Plan that must be in place prior to starting Human Factors & Usability activities. (12 pages + 1 form)

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

$150.00

This SOP explains how to document the use of the device including user profiles and use scenarios. (9 pages + 4 forms)

$150.00
This SOP describes the procedure for conducting a usability hazard analysis following ISO 14971. The results of the hazard analysis are factored into the usability requirements. (14 pages +3 forms)
$150.00

This SOP explains how to document the hardware/ software user interface using the Usability Specification and Hazard Analysis as input. (7 pages + 2 forms)

$150.00

This SOP describes the procedure for preparing a plan for the activities  for the evaluation of the user interface (12 pages + 5 forms)

$150.00

This SOP describes the activities necessary to verify the design (7 pages + 1 form)

$150.00

The Usability Validation SOP describes the activities necessary to demonstrate that the device conforms to User Usability requirements and intended uses. Usability Validation is very different than device validation(11 pages + 4 forms)

Webinar slides that explain the SOP and the context of the SOP are included. These could be used for training.

$200.00

The Human Factors Engineering Report is a summary of all HF studies conducted for the device. The conclusions and rationales that are necessary to be included are described. (9 pages + 4 forms)

$150.00