
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

-
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.