Service Description

We help rescue misaligned summative studies, getting them back on track with FDA expectations before final submission. If your human factors validation study is off-track, we step in to realign it and fix issues before it collapses or causes costly delays. Who It’s For: Medical device teams in mid-submission chaos – where the validation protocol doesn’t align with FDA expectations, critical task identification is flawed, or the IFU introduces more confusion than clarity. Includes: ✔ Review and markup of:
  ■ Human Factors Summative (Validation) Protocol
  ■ Instructions for Use (IFU)
  ■ Critical task mapping and URRA alignment
 ✔ Restructured and/ or corrected task analysis and critical task identification
 ✔ Risk-based study rationale to support protocol design and justification
 ✔ 'Study Rescue Action Plan' – Clear, prioritized steps to fix things fast - a corrective action plan that guides your next steps
 This package is ideal for regulatory leads, design teams, or program managers who need expert help getting a misaligned protocol back on track – fast. Flat Fee: $9,495+ (based on scope)
 Timeline: 7–10 business days Optional Add-On: ■ 1-Hour HFE Strategy Advisory Call for $495 ■ Follow-Up HFE Document Review for $695+
 ■ Reconstruction of HF Study Protocol for $4,495+