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Expert Human Factors Help.
When You Need It. How You Need It.
Clinic
Flat-Fee Human Factors and Usability Engineering and Regulatory Strategy Services for Medical- and Drug-Device Combination Product Teams - aligned with FDA, IEC 62366, and AAMI HE75.
We created HFUX Clinic for teams under pressure facing — FDA deadlines, internal design reviews, or regulatory audits — with no time to waste. Our flat-fee service packages give you direct access to expert human factors guidance, without the delays, confusion, or scope creep of traditional consulting. Check out our new HFUX Clinic services.
research | design | ENGINEER | test
what we DO
At HFUX Research we consider it our priority to advocate for users and patients by verbalizing their needs, ensuring their safety, and elevating their user experience through innovative and intuitive human-focused design.
Human factors isn't just a regulatory requirement; it is our philosophy.
Our goal is to provide customized human factors and usability strategies and solutions tailored to meet each organization's research and development needs. We want to help our clients to achieve their human factors vision and usability goals and empower them to design and develop the safest and most effective products possible.
all HFUX ResearchSERVICES
Whether you are looking to...
✔ identify human factors engineering and regulatory strategy
✔ perform initial research and explore product ideas and concepts
✔ implement HF/UE program and procedures
✔ develop use specification
✔ identify intended use, users, and environments
✔ gather and identify user needs and product requirements
✔ develop and implement known use and use-related risk analyses
✔ identify use scenarios and critical tasks
✔ render initial UI wireframes, mockups and UX designs
✔ define user interface characteristics and specifications
✔ develop and usability test low or hi fidelity prototypes
✔ optimize user workflow with intuitive information architecture
✔ conduct usability testing with real-world users
✔ perform competitive benchmark and comparative use testing
✔ design, develop, and evaluate labeling and packaging, instructions for use (IFU), quick reference guides (QRG), and prescribing information (PI)
✔ perform threshold and heuristic analyses
✔ execute formative and human factors summative studies
✔ perform parallel FDA and MDR usability validation testing
✔ conduct human factors Annex C remediation
✔ gap and threshold analyses and HFE, FDA, and MDR reporting
✔ prepare HFE and UE file for FDA and EU/MDR submission
... discover our research, design, ENGINEER, and test services below and learn more about how we can help you in realizing your human factors vision and usability goals.
idea
research it.
human
factors and user
RESEARCH
...qualitative and quantitative
human factors and usability
research methods...
exploratory research
generative HF research
real use user research
observational field research
contextual inquiry
focus groups
use scenarios and personas
gap analyses
expert reviews
user experience
and interface
DESIGN
...diverse user experience and interface design approaches...
UX, HCI, UID design
interaction design
GUI mockups and wireframes
hi and low fidelity prototyping
information architecture
device labeling and packaging,
instructions for use, quick reference
guides, and prescribing information
concept
design it.
development
ENGINEER IT.
human
factors and usability
ENGINEERING
...comprehensive human factors
and usability engineering...
HF and regulatory strategy
HF plan and use specification
known use error and
use-related risk analyses (URRA)
task and workflow analyses
FDA, IEC 62366, and
MDR alignment and adherence
gap and threshold analyses
HFE FDA and MDR reporting
usability and
evaluation
TESTING
...wide-ranging user and
usability testing methods...
remote usability testing
formative usability testing
summative usability validation
heuristic evaluations
A/B directional testing
agile usability testing
usability benchmark
comparative use testing
cognitive walkthroughs
evaluation
test it.
product
