Regulatory Assist

Usability Engineering (IEC 62366)

Design devices that are safe, effective, and intuitive to use.

What We Do

Human factors engineering is critical for preventing use errors. We guide you through the usability engineering process, from defining user profiles to conducting summative validation testing.

  • Use Specification: Defining intended users, use environments, and critical tasks.
  • Use Error Analysis: Identifying potential use errors and implementing risk controls.
  • Formative Testing: Iterative testing to improve design and identify usability issues early.
  • Summative Validation: Final testing to prove safety and effectiveness for submission.

Deliverables

Usability Engineering File
Task Analysis
Test Protocols & Reports
HFE/UE Report