UEHF Awareness for Medical Devices
Spot the use error. Ask the right questions.
A short, self-paced course for the people who review, approve and work alongside usability engineering. Learn why use errors are design problems, how critical tasks are found and what formative and validation testing prove, without having to become a human factors specialist.
Training a team or paying by purchase order? Email us
Enter the meal’s carbs in the app
Enters 150 g instead of 15 g
Severe low glucose: a critical task
“Unusually high” warning and dose confirm; HF validation
By the end of the course you can read a row like this and spot when it’s weak.
For everyone who works alongside usability engineering, not just the human factors specialist
If use-related risk, HF test reports or FDA human factors questions land on your desk, this course gives you the vocabulary and the questions.
Managers and executives
Know what good usability engineering looks like before you sign off on it.
Project Managers and sponsors
Plan for formative rounds and HF validation before they hit the schedule.
Cross-functional team members
R&D, marketing, clinical and operations: contribute with confidence.
Quality and regulatory
See how the URRA links to ISO 14971, design validation and FDA submissions.
New hires
Get up to speed on how your company designs for safe use.
Suppliers
Understand what your customer needs from your part of the user interface.
Four things you’ll take into your next design review
See use errors as design problems
Know what counts as a use error and as the user interface, and why blaming the user fixes nothing.
Find the tasks that matter
Follow how the use specification and the URRA identify the critical tasks that drive the whole program.
Judge the design and the testing
Recognize good interface design, and what formative evaluation and HF validation each prove.
Know what reviewers expect
What goes in the usability engineering file, the FDA submission categories, EU requirements, and the mistakes reviewers flag.
Eight short modules, one example all the way through
Every module follows SmartPANC, an artificial pancreas system, so each idea builds on the last. A short check closes each module.
Orientation
Where UE/HF fits in the regulatory landscape, and the SmartPANC system we’ll follow.
Why use errors matter
Use error, the user interface, what is in scope, and critical tasks.
Users, uses and environments
The use specification, user groups, use environments and task analysis.
Use-related risk analysis
The URRA, perception-cognition-action, and the risk control hierarchy.
Designing the interface
HE75 principles for controls, displays, alarms and labeling.
Formative evaluation
Testing early and often, methods, and challenging the design on purpose.
HF validation testing
Fifteen per user group, training and learning decay, and reading the results.
File, submissions and lifecycle
The UE file, FDA categories, the EU, post-market and a 15-question final check.
Start here, or go straight to running the UE process
Not sure which one you need? Awareness is for people who read and review UE/HF work. The full course is for the people who plan, run and document it.
UEHF Awareness for Medical Devices
- Read and question a URRA and HF test plan
- Understand critical tasks and risk controls
- See how UE connects to ISO 14971 and FDA submissions
- Certificate of completion
$249
Enroll nowUsability Engineering and Human Factors (UEHF) for Medical Devices
- Build the use specification, URRA and UE file
- Plan formative studies and HF validation testing
- Templates and a procedure ready to use
- Full $249 credit if you upgrade within 30 days
$1,500 before your credit
See the full course
Dr. John Salvato
Founder and President, Design Quality Services
More than 30 years in medical device and automotive quality and regulatory work. John has built and defended usability engineering and risk management programs for device makers around the world.
Top Medical Device Consulting 2026, MedTech Business ReviewBefore you enroll
Do I need any human factors experience?
How long does it take?
How does the upgrade credit work?
Do I get a certificate?
Can I enroll my whole team?
Walk into your next design review knowing what to ask about use errors.
Two and a half hours, one worked example, and a certificate at the end.
Enroll for $249Ready to run the full UE process instead? See the full course
Training a team or paying by purchase order? Email us