Service Description

We thoroughly review your entire human factors/usability engineering file to ensure it’s ready for FDA scrutiny, so you can submit with confidence. Our team checks HFE documentation (plans, analyses, protocols, reports) and flags any gaps or compliance issues early. Who It’s For: Medical device teams approaching a 510(k), IDE, or De Novo submission who need a final expert review of their HFE file to catch compliance gaps before submission – or before internal regulatory review. Includes: ✔ Review of 3 key documents (choose from):
  ■ HFE/UE Report
  ■ Use-Related Risk Analysis (URRA) or uFMEA
  ■ Instructions for Use (IFU)
  ■ Human Factors Summative (Validation) Protocol
 ✔ Identification of red flags and compliance gaps
 ✔ Actionable recommendations aligned with:
  ■ FDA Human Factors Guidance
  ■ IEC 62366
  ■ AAMI HE75
 ✔ 5–7 high-priority action items to resolve before submission This package is ideal for startups, design firms, or cross-functional teams seeking clarity before locking in decisions that could jeopardize FDA acceptance or delay time-to-market. Flat Fee: $8,495+ (based on scope)
 Timeline: 7–10 business days Optional Add-On: ■ Follow-Up HFE Document Review for $695+
 ■ Reconstruction of HF Study Protocol for $4,495+ ■ 1-Hour HFE Strategy Advisory Call for $495
 NOTE: Recommended for teams navigating multiple regulatory paths or needing clarification before implementation.