Design User Interfaces that minimize Use Errors and make customers happy.
Define Use Specifications, build sound URRAs, and develop robust UI Evaluation Plans that align with IEC 62366-1 and 2026 FDA guidance, practiced on a sample device.
Training a team or paying by purchase order? Email us
9 chapters · about 16–20 hours · IEC 62366-1 and 2026 FDA HF guidance
Top Medical Device Consulting 2026 MEDTECH Business ReviewHands-on with a sample device SmartPANC, with DQS answers
- Use Error
- User error
- Cause
- Did not follow the IFU
- Control
- Training and a warning in the IFU
- Critical?
- Use Error
- Confirms 5.0 U bolus when 0.5 U was intended
- PCA cause
- Perception: decimal point hard to see
- Control
- Leading zero, larger decimal, dose confirmation step
- Critical?
The usability file exists. It just isn't finding anything.
- Human Factors work starts after design freeze, so every finding is expensive to fix.
- The URRA lists "user error" as the cause and "training" as the control.
- Nobody is sure which tasks are critical, so Summative testing covers everything, or the wrong things.
- FDA asks for your Human Factors submission category, and the file can't answer it.
That isn't a lack of effort. It's the lack of a process that connects users, Use Errors, design and validation. This course teaches that process.
How does your usability work hold up?
Answer for the most recent device your team took through Human Factors work. Your answers stay on this page and aren't sent anywhere.
- Did your Human Factors work start before design freeze?
- Is each Use Error in your URRA traced to a perception, cognition or action cause, not "user error"?
- Can you name your Critical Tasks, and does Summative testing focus on them?
- Do your risk controls start with labeling and end with training?
- Do you know which FDA Human Factors submission category your device falls in?
"Great material. Best I've ever seen in the industry."Mike Z.Senior Management Consultant
After the course, your team will be able to
Find the real root cause of a Use Error
Build User Profiles and a Use-Related Risk Analysis, then use the Perception-Cognition-Action model to see why an error happens, not just that it can.
Design the error out first
Identify Critical Tasks and apply HE75 principles for controls, displays, alarms and labeling, so training is the last line of defense, not the first.
Run testing that holds up
Plan Formative Evaluations that improve the interface, and HF Validation with the right participants, training and acceptance criteria.
Answer the reviewer before they ask
Determine your FDA Human Factors submission category and write a Usability Engineering File that is clear, verifiable and complete.
Built for the people who design, test and defend the User Interface
See who it's for, and who it isn't
This course is for you if
- You are a design or R&D engineer whose device has a User Interface, labeling or instructions.
- You own or contribute to Human Factors work and want one coherent IEC 62366-1 and FDA process.
- You work in quality or regulatory and review the Usability Engineering File before submission.
- You are preparing a submission under FDA's 2026 Human Factors guidance and need to pick the right category.
- You lead a team and want usability built into development, not bolted on at the end.
It is probably not for you if
- You want a one-hour overview of usability vocabulary.
- You are looking for a test report template without changing how your team designs.
Four stages, from intended users to a finished usability file
Every stage ends with hands-on work on the SmartPANC sample device, plus quizzes to confirm you have it before moving on.
Foundations and users
Why usability engineering matters, the standards and FDA framework, and a Use Specification built on real user characteristics.
Chapters 1–2Risk and design
Use-Related Risk Analysis, Critical Tasks, root causes with PCA, and HE75 design principles that remove errors at the source.
Chapters 3–4Evaluate and validate
Formative Evaluations that shape the design, then HF Validation testing with the right protocol, participants and data.
Chapters 5–6Document and sustain
The Usability Engineering File, post-market and change management, FDA submission categories and clear technical writing.
Chapters 7–9- 16–20 hrs of learning in 150 lessons
- 15 quizzes plus a final exam
- Hands-on exercises on SmartPANC, each with DQS answers
- Downloadable course materials
Not sure yet? Start Chapter 1 free. You get access inside the course as a student, including the first SmartPANC exercise and quiz, before you decide.
Chapters marked "Your gap" match the answers you gave in the usability check.
- Introduction and FoundationsYour gap
- Use SpecificationYour gap
- Use-Related Risk Analysis (URRA)Your gap
- ANSI/AAMI HE75 Design PrinciplesYour gap
- Formative EvaluationYour gap
- Human Factors Validation TestingYour gap
- Documentation and the UE FileYour gap
- Post-Market and Lifecycle ManagementYour gap
- Regulatory Expectations and Technical WritingYour gap
Usability is a team sport. Train the team on one process.
When design, quality and regulatory share the same method, Use Errors get caught earlier, testing is scoped correctly, and the submission tells one consistent story.
- A shared vocabularyOne way to write Use Errors, Critical Tasks and risk controls across every product line.
- Pairs with the rest of the librarySafety Risk Management, Design Validation and DFMEA courses build on the same foundation.
- Impact your business positivelyInvestment in professional development is not a 'nice-to-have'. It has real, tangible benefits.Get the white paper
Dr. John Salvato
John has spent more than 30 years in medical device and automotive quality and regulatory work. Since founding DQS in 2017 he has built usability engineering, design control and risk management methods for device makers around the world, and defended that work with agencies and regulatory bodies.
"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."
Questions people ask
Can I try it before I buy?
How much time does it take?
Does it cover FDA's 2026 Human Factors guidance?
I'm not a Human Factors specialist. Will I keep up?
How does usability engineering relate to ISO 14971?
Catch the next Use Error in design, not in the field.
Learn a usability process your team can defend in every design review, audit and submission.
$1,500 · self-paced · start today
Training a team or paying by purchase order? Email us