Presentation
MDD1 - A framework for scaling your usability effort and determining what content to include in your submission
DescriptionThe FDA released a draft guidance document in late 2022 that provides recommendations on what content to include in your medical device marketing submission. Similarly, AAMI-IEC-ANSI 62366-1 contains provisions for tailoring the usability engineering effort.
This presentation introduces a framework that incorporates the recommendations from the FDA draft guidance and the AAMI-IEC-ANSI standard to help manufacturers and human factors professionals determine what human factors activities are appropriate for a project, document the activities performed during this determination, and communicate the conclusions and rationale to the appropriate authorities.
Applying this framework will allow manufacturers and human factors professionals to right-size their human factors efforts while avoiding unnecessary surprises with submissions.
The presentation will include examples and steps through the decision-making process of the framework. These examples will include audience participation elements to encourage active discussion with other industry stakeholders and professionals.
This presentation introduces a framework that incorporates the recommendations from the FDA draft guidance and the AAMI-IEC-ANSI standard to help manufacturers and human factors professionals determine what human factors activities are appropriate for a project, document the activities performed during this determination, and communicate the conclusions and rationale to the appropriate authorities.
Applying this framework will allow manufacturers and human factors professionals to right-size their human factors efforts while avoiding unnecessary surprises with submissions.
The presentation will include examples and steps through the decision-making process of the framework. These examples will include audience participation elements to encourage active discussion with other industry stakeholders and professionals.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives