Usability Engineering

Designing Devices That Are Safe, Intuitive, and User-Centered

Poor usability is a leading cause of medical device recalls and adverse events. At PulseForward, we help ensure your devices are safe and effective for real-world users—from patients to clinicians—through structured Usability Engineering aligned with IEC 62366-1 and FDA Human Factors guidance.

Our team works with you from early user research through formative evaluations and summative testing, building a complete Usability Engineering File that supports compliance and patient safety.

Our Services Include:

• User Research & Context of Use Analysis
  Identifying target users, environments, and workflows to define realistic use scenarios and uncover critical needs early in development.

• Use Error Risk Analysis
  Integrating usability into your risk management process by identifying potential use errors that could lead to harm, and mapping them to design mitigations.

• Formative Usability Testing
  Conducting iterative user testing with wireframes, prototypes, or devices to validate and refine key interactions and user interface elements.

• Summative (Validation) Testing
  Designing and executing validation studies with representative users under simulated-use conditions to demonstrate safe and effective use per FDA and IEC requirements.

• Usability Engineering File Development
  Documenting the process and evidence in a structured file ready for regulatory submission or audit.

Why It Matters:

Good usability is not just good design—it’s a regulatory requirement. A strong usability engineering process reduces risk, improves user satisfaction, and can be the difference between market success and regulatory delays. With PulseForward, you gain a partner who understands both the human and regulatory sides of device development.