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Illuminating
The Path 
Forward With
Human-Inspired Solutions

Human Factors Engineering

Risk Management

Training & SOPs

Product & Process Design Support

What We Offer

Big-Firm Expertise, Small-Firm Agility

As a small consulting firm, we provide flexible, specialized human factors support tailored for medical devices and combination products. We recognize that every project is unique - and important. Our adaptable methodology enables us to integrate seamlessly with your team, delivering targeted human factors expertise that drives successful usability and regulatory outcomes for your products and operations.

1) Consultants with a 360° Perspective

Firsthand industry experience in product development, quality assurance, and human factors research gives us a unique understanding of industry challenges.

 

​2) Proven Expertise in Study Execution

Backed by extensive moderation experience, we ensure usability studies are executed successfully and align to evolving regulatory expectations.

 

​3) Methodical Approaches in Everything We Do

From consulting strategy to study execution to regulatory reporting, we take a detailed, results-driven approach to help you reach your goals.

No unnecessary overhead. No extra complexity. Just the precise support you need.

Contact Us for more details.

What We Can Do For You

Human Factors Studies

  • Cognitive Walkthroughs

  • Formative Evaluations

  • Summative / Validation Studies

  • Study Documentation

    • Protocols / Reports

    • Moderator Guides

    • Recruitment Screeners

Human Factors Analyses

  • Known Use Problems Analysis

  • Task Analysis / Use Error Analysis

  • PCA Analysis

  • Heuristic Analysis

  • Use-Related Risk (URRA, uFMEA)

  • Design Modification Reviews

HF Planning /  Reporting

  • HFE / UE Planning

  • Human Factors Training

  • HFE / UE Procedures

  • HFE / UE Templates

  • Usability Engineering File (UEF) Support

  • FDA HFE / UE Reporting

Manufacturing Applications

Automated Vaccine Production
  • Human Factors Training

  • NC Investigation / CAPA Support

  • Process Task Review

  • Process Risk Mgmt. Support

  • Cognitive Interview Training

  • HF / Lean Integration

  • Design Transfer HF Support

Check out our full service offerings.

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