︎

Out-of-the-Box Medical Device Safety



Executive Summary: Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications related to IEC 62366-1. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced through human factors engineering by conducting usability studies related to the out-of-the-box experience.

Read the full paper here!

︎ UserWise, a ClariMed Company | December 22, 2016
Related Posts

About Us


Our consultants partner with medical device companies to fulfill any and all steps of the Usability Engineering Process.

UserWise offers a wide range of services spanning the product development cycle. Our consultants assist in performing user research, constructing the use-related risk analysis, conducting formative evaluations, executing summative usability validation testing, refining user manuals, compiling the Usability Engineering File and FDA Human Factors/Usability Engineering Submission Report, and so much more. 

Learn more

UserWise, LLC
Office Hours
Monday-Friday 9:00 AM - 5:00 PM PT


Copyright © 2023 UserWise, LLC. All rights reserved.