As a medical technology developer who seeks to apply human factors engineering (HFE) effectively to produce safe and effective devices and to satisfy regulators’ requirements and expectations, you may be frustrated that pre-existing guidance only describes how to perform specific HFE techniques but does not provide sample work products (e.g., test plans, test reports).
A new webinar from AAMI, in conjunction with the release of Writing Human Factors Plans and Reports for Medical Technology Development, has been developed to fill a perceived gap in the guidance available to medical technology developers like you.
The webinar and publication provide sample work products and supplemental job aids that offer document preparation advice and have been peer-reviewed by a panel of HFE experts.
For more info: http://www.aami.org/events/eventdetail.aspx?ItemNumber=5711