Device Labeling and Documentation, Instructional Materials, and Training

Based on human factors principals and FDA guidelines, we develop and evaluate medical device labels and documentation.

• Reduce potential for user error
• Perform task analysis to decompose complex processes into basic steps
• Develop graphics to demonstrate required actions with use of limited text
• Ensure FDA labeling requirements are met
• Enhance international marketing through use of icons

We develop quick reference guides (QRGs) to give users initial instructions for using produces.

• Assess graphics for visibility and ease of understanding
• illustrate step-by-step procedures
• Highlight critical task elements
• Use succinct text to complement graphics
• Design graphics and text based on human factors standards and guidelines for the range of user characteristics