Med Device Advisors Sells Medical Device SOP's
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Categories SOPs_Available 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.
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This group of SOP's will allow you to create a compliant program following ISO 62366 and the latest FDA Guidances. Select this item to order all titles below at a reduced price. $1100
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$1,100.00
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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. $200 |
$200.00
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This SOP explains how to document the use of the device including user profiles and use scenarios. (9 pages + 4 forms) $150 |
$150.00
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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) $200 |
$200.00
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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 |
$150.00
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This SOP describes the procedure for preparing a plan for the activities for the evaluation of the user interface (12 pages + 5 forms) $150 |
$150.00
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This SOP describes the activities necessary to verify the design (7 pages + 1 form) $200 |
$200.00
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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 |
$200.00
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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 |
$150.00
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