Learn how to establish a pragmatic usability engineering process that enables regulatory clearance and great product design during this self-paced, interactive online course.


Course length 8-16 hours
Course fee
(per person)
€ 399

Course description

This online course focuses on a pragmatic usability engineering approach. The course is suitable for anyone working in product management, such as R&D and QA engineers, product and application specialists, and product owners.

The course covers an orientation of the usability engineering process according to the IEC 62366-1:2020 version of the standard as well as the pragmatic translation of the standard to everyday life.

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Michaela Kauer Franz

The instructor is the CEO of Custom Medical, an award-winning company that designs user interfaces for medical devices and is conducting formative and summative usability studies for all classes of medical devices. She is a lecturer for the design of medical and critical user interfaces at the Technische Universität Darmstadt and part of the national standardization committees in Germany for Usability and User Experience.

Dr. Michaela Kauer-Franz is a highly esteemed trainer, consultant, and entrepreneur in the medical device industry. With her scientific background and her unique combination of psychological background and PhD in Technology Acceptance from the Department of Mechanical Engineering of Technische Universität Darmstadt, she is the perfect Instructor for engineers that want to delight their users whilst sticking to the regulatory requirements for usability engineering.

She has vast hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products. Michaela Kauer-Franz has received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award.

Benefits for you

 Become confident in planning usability engineering

The goal is that upon completion of this course, you should understand the overall process of usability engineering and how to create intuitive, easy-to-use and safe medical devices. You should also be able to plan appropriate formative studies and get an impression of the agenda for the final summative evaluation.

Self-paced learning

You will have access to the course for 6 months. The great thing about our online courses is that you can stop, repeat and resume as many times as you like during this time! This provides you with the flexibility to learn how and when you want. This is especially valuable in the usability process because it is done iteratively and thereby sometimes needs a short refresher.

 Course certificates to prove to regulatory bodies you know your stuff

Auditors will look for evidence that you are competent in usability engineering. You will have a nice-looking course certificate to bring up if you will get the question during an audit. Avoid the discussion with the auditor if you know usability engineering or not.

Course programme

0 Base Course
Lesson 1. Introduction
  • Welcome
  • What you need to know
  • Set your course goal completion date
  • Pre-course assessment quiz
  • Why usability engineering and why is it important?
Lesson 2. Meet two close friends: Usability Engineering and Risk Management
  • The usability engineering process and key terms
  • Talking about usability means talking about risk
  • How to structure and share work
Lesson 3. The regulatory background for usability engineering
  • The regulatory background for usability engineering
  • Differences between Europe and the US
  • What is new in IEC 62366-1:2015/1 Amd 2020?
Lesson 4. Understanding and cherishing iterative work
  • Usability engineering as an iterative process: Where to start and where to stop
  • Your mindset as usability engineer
Lesson 5. The general requirements of usability engineering
  • Usability engineering planning and file
  • How about user experience? A pragmatic approach to great products
Lesson 6. Preparing the use specification
  • How to learn about your users?
  • Interviews & observations
  • Contextual inquiries
  • How to UX from the start?
Lesson 7. Identifying user interface characteristics related to safety
  • What is task analysis and why to perform one?
  • How to use the results?
Lesson 8. Focusing on relevant things
  • Identifying known or foreseeable hazards and hazardous situations
  • Describing hazard-related use scenarios
  • Choosing evaluation scenarios for summative testing
0 Base Course
Lesson 9. Establish user interface specification
  • From contextual inquiry to the requirement
  • Your wish is my command?
  • How to phrase user requirements correctly
  • Delighting User with UX requirements
Lesson 10. Establish user interface evaluation plan
  • To test or not to test: This is here the question.
  • When to start?
  • How often should I test?
Lesson 11. Design user interface
  • A short introduction to design guidelines
  • Prototyping: making the device experienceable.
  • From low budget to high gloss
  • Building fast means failing fast, means learning fast
  • Good usability is not good UX
Lesson 12. Performing formative tests
  • How and when to do formative testing? – part 1
  • How and when to do formative testing? – part 2
  • What to test and how to integrate UX into usability testing?
Lesson 13. Performing summative evaluation
  • Doing the final exam: The basics of summative testing – Part 1
  • Doing the final exam: The basics of summative testing – Part 2
  • Analyzing errors with a route cause analysis
Lesson 14. Final exam
  • Final exam
Lesson 15. Course evaluation
  • Course evaluation

NOTE – The course program structure is subject to change.

Frequently asked questions

Is the course a live webinar?

The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You cannot download the course though, thus you will need to have an internet connection to take the course.

How long does it take to complete the course?

All in all, the average time to complete the course is 8-16 hours. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.

How long will I have access to the course?

You will have access to the course for six months.

What if I lose internet connection during the final exam?

You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.

Can I fail the final exam?

There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!

Where can I find my course certificate?

The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.

What payment methods will you accept?

You can pay using a credit card. You will receive a receipt of payment over email. You can select to pay by invoice instead of credit card at the end of the check-out process. Please note, if you would like to be invoiced, this will take longer and you may incur an invoicing fee.

Can I view the course on a mobile device?

Yes, you can. The course is in HTML5 format which will play on any new iOS or Android devices.

Do you offer volume discounts?

If you buy more than 5 seats, you may want to consider group purchase, which will give you discounted prices for seats on the course. Reach out to us using the contact form below and let us know how many seats you are interested in purchasing.

Can a colleague and I take the course at the same time?

The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the course.

Is the instructor accredited or certified to give this training?

Dr. Michaela Kauer-Franz is TÜV Rheinland certified Medical Devices Usability Expert and is giving training for a lot of renowned companies and training facilities. In general, there is no certification or accreditation for usability engineering that needs to be done, however, the instructor has conducted training in the field for many years and is working together with experts from other fields to enable the highest training standards possible.

What are the pre-requisites for this course?

There are no pre-requisites for this course.

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