TMF HF&UC

Eliminate Use Errors. Accelerate Market Approval.

Human Factors consulting for safe, effective, and compliant products.

The Cost of Poor Usability

Regulatory Rejection

Delayed approvals and costly redesigns due to non-compliance.

Product Recalls

Expensive recalls damaging your brand reputation.

User Injury

Potential harm to users leading to liability issues.

Brand Damage

Loss of consumer trust and market share.

TMF provides comprehensive solutions to identify and mitigate these risks early in your development process, saving you time and money.

Our Regulatory Expertise

We specialize in preparing Human Factors documentation that meets rigorous regulatory standards, ensuring your submission is complete and compliant.

FDA Human Factors Guidance (2016)

ISO 14971 (Risk Management)

IEC 62366-1 (Usability Engineering)

Submission-Ready Reports

Our reports are structured to meet regulatory expectations, including:

  • Use-Related Risk Analysis (URRA)
  • Formative & Summative Evaluation Reports
  • Human Factors Engineering Report (HFER)
  • Use Specifications & Interface Design Documentation

Quantifiable Results

45%

Reduced Critical Errors

Through iterative design improvements based on human factors testing

98%

Task Completion Rate

After implementing our interface optimization recommendations

100%

First Review Cycle Approval

FDA clearance achieved without additional data requests

Case Study: Medical Device Interface

For a Class II medical device, we identified 22 use-related risks during formative testing. After redesign, summative testing showed zero critical errors with intended users.

Our Clients' Challenges

Clinical Interfaces

Designing intuitive interfaces for complex medical workflows under time pressure

Automotive Systems

Validating driver interaction with infotainment and ADAS systems

Consumer Apps

Ensuring safety of medical apps used by consumers without training

Begin Your HF Validation

Our team will help you navigate the human factors requirements specific to your product and development stage.

Email

tmfchat@tmfhumanfactorsusabilityconsulting.com

Phone

+1 (640) 259-5957

Location

9339 LASAINE AVE, NORTHRIDGE, CA 91325

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