User Feedback & Testing

Real-World Validation to Improve Safety, Usability, and Adoption

We test through the process at key points  to gather feedback on your design to validate and improve performance.

Why It Matters

User feedback is needed  to validate performance and usability. Testing with real human users allows us to  identify areas of the device that are challenging to use so that we can  adjust and ensure that the final device fits seamlessly into clinical use.

Our Approach

Formative and summative evaluations are conducted throughout the process, including task analysis, simulated use, and iterative testing. Our team develops the proper documentation needed for the FDA to support your Human Factors Engineering (HFE) file.

Our User Feedback & Testing Services Include:

  • Cognitive Walkthroughs

  • Task Analysis

  • Use-Related Risk Analysis

  • Heuristic Evaluations

  • Formative Evaluations

  • Summative Evaluations

  • Iterative Design Testing

  • Use Specification

  • User Interface & Interaction Specification

  • Use Requirements Documentation

  • Voice of Customer (VoC) Interviews

  • User Profiles and User Groups

  • Clinical Procedure Mapping

  • Potential Use Error Analysis

  • KOL (Key Opinion Leader) Interviews and Feedback

  • HF/UE Reports for FDA Submissions

  • Compilation of Full HF File

  • Instructions for Use (IFU) – Creation, Evaluation, and Validation

What You Get

Validated user requirements, actionable design refinements, and a complete FDA-ready Human Factors report to support regulatory approval.