Service Description

We identify what’s missing in your HFE documentation – before the FDA does (or your budget runs out). This quick-turnaround gap analysis finds any overlooked requirements or usability risks, giving you a clear action list to close those gaps fast. Who It’s For: Startups, early-stage teams, or R&D leads working under design control who need to align with FDA human factors expectations before locking in their design or heading into summative testing. Includes: ✔ Audit of 2–3 critical HFE documents (e.g., early protocols, IFUs, use specification, task analysis, URRA, rationale documentation, etc.)
 ✔ Strategic Gap Summary outlining:
  1. What’s missing
  2. What’s at risk for FDA rejection or deficiency
  3. A clear roadmap to get back on track before validation
 ✔ Priority checklist with short-, medium-, and long-term actions This package is ideal for startup accelerators, design partners, or R&D teams in pre-summative planning mode who want clarity before committing time or money to the wrong path. Flat Fee: $7,495+ (based on scope)
 Timeline: 5-7 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+