Service Description

If your usability test protocol needs more than a light edit, let us rebuild it from the ground up. We reconstruct your study protocol to align every detail with FDA expectations, covering: objectives and scope, critical tasks, methods, user instructions, success criteria, and data collection. The result is a robust protocol ready for regulatory approval. Includes: ✔ Critical task mapping ✔ Study objectives, scope and goals ✔ Study methodology and approach ✔ Study procedure and test activities ✔ Use scenarios and pass/fail criteria aligned with FDA guidance ✔ Scope-based pricing depending on complexity and device type Flat Fee: $4,495+ (scope based) Timeline: 7–10 business days Optional Add-On: ■ 1-Hour HFE Strategy Advisory Call for $495 ■ Follow-Up HFE Document Review for $695+