Medical device usability testing services
We provide global medical device usability testing services including an expert review, formative usability testing, and summative human factors validation testing.
Expert review
An expert review is a structured design evaluation performed by our human factors engineers. The goal of an expert review is to identify potential use-related risks and opportunities for design improvement.
An expert review can be conducted on a complete medical device, specific user interface elements, instructions for use (IFU), reference guides, and other user-facing materials.
Cost-effective alternative to early-stage user testing
Focuses on a review of a device prototype, labelling, or specific user interface elements
Based on industry-standard heuristics and medical device design guidelines
Provides a detailed report with actionable design recommendations
Formative usability test
Conduct a formative usability with representative users early and iteratively during the design phase to timely identify use errors and explore design opportunities for improvement.
Evaluate the usability of a product with intended users
Timely identify use errors and optimize medical device design
Design medical devices that are safe, effective and intuitive
Reduce the risk of observing critical use errors during the summative test
Summative usability test
Conduct a summative usability test (also knowns as a “human factors validation test”) in compliance with regulatory expectations. This usability study provides evidence that your device can be used safely and effectively by the intended users within the intended use environment(s).
Formal final validation of a production-equivalent medical device and labelling
Thorough critical task evaluation
Compliant with MDR, FDA, NMPA, ISO 14971, and IEC 62366
Submission-ready test report
How can we help?
Schedule a free consultation or request a quote for your human factors and usability engineering needs.
Contact Us
info@hf-insight.com