Goals:

Develop Instructions for Use for 4 CareGuide Product lines

• Versions for clinical, research and mobile use
• Intuitive and concise to facilitate use compliance
• FDA compliant

Roles:

• Write verbal instructions and layout graphics
• Design placement illustrations and device labels in Illustrator
• Human factors testing of designs with end user populations
• Perform updates based on software changes, user feedback, simplified graphics

Results:

Multiple IFUs developed

• Included in 4 successful FDA 510(k) submissions, 1 pending application
• Used by operators at over 10 clinical, military, and research sites across the United States and in Thailand