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

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

This online course focuses on a pragmatic usability engineering approach. It covers an orientation of the usability engineering process according to the IEC 62366-1:2020 version of the standard as well and how to effectively implement the requirements of the standard.

Topics covered include: the general requirements of usability engineering, preparing the use specification, establishing user interface specification and evaluation plan, designing user interface, and performing formative and summative evaluations.

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 online course is made up of pre-recorded videos, quizzes, and a final exam. You will have access to the course for 6 months from enrolment and will receive a course certificate upon successful completion of the course.

Michaela Kauer Franz

Dr. Michaela Kauer-Franz is the CEO of Custom Medical, an award-winning company that designs user interfaces for medical devices and conducts formative and summative usability studies for all classes of medical devices. She holds lectures on the design of medical and critical user interfaces at the Technische Universität Darmstadt and is part of the national standardization committees in Germany for Usability and User Experience.

Dr. Michaela Kauer-Franz is a highly regarded trainer, consultant, and entrepreneur in the medical device industry. She has extensive hands-on experience, having developed, amongst other things, monitoring devices for ICU and NICUs, diabetes care products, and women’s health products. She has also received numerous awards including the Red Dot Winner Interface Design Award and being nominated for the UX Design Award.

Benefits for you

Checkmark MDHQ 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.

Checkmark MDHQ 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.

Checkmark MDHQ 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

  • Welcome
  • What you need to know
  • Set your course goal completion date
  • Pre-course assessment quiz
  • Why usability engineering and why is it important?
  • The usability engineering process and key terms
  • Talking about usability means talking about risk
  • How to structure and share work
  • The regulatory background for usability engineering
  • Differences between Europe and the US
  • What is new in IEC 62366-1:2015/1 Amd 2020?
  • Usability engineering as an iterative process: Where to start and where to stop
  • Your mindset as usability engineer
  • Usability engineering planning and file
  • How about user experience? A pragmatic approach to great products
  • How to learn about your users?
  • Interviews and observations
  • Contextual inquiries
  • How to UX from the start?
  • What is task analysis and why to perform one?
  • How to use the results?
  • Identifying known or foreseeable hazards and hazardous situations
  • Describing hazard-related use scenarios
  • Choosing evaluation scenarios for summative testing
  • From contextual inquiry to the requirement
  • How to phrase user requirements correctly
  • To test or not to test: This is the question
  • When to start and how often should I test?
  • Short introduction to design guidelines – Part 1
  • Short introduction to design guidelines – Part 2
  • Prototyping from low budget to high gloss: Making the device experienceable
  • Building fast means failing fast, means learning fast
  • 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?
  • The basics of summative testing – Part 1
  • The basics of summative testing – Part 2
  • Analysing errors with a root cause analysis
  • Course evaluation

NOTE – The course program structure is subject to change.

Do you think you will learn more from a classroom course?

This course is also delivered as a blended course, where we combine the best of two worlds. You start with the online course, and then attend a live virtual 1-day classroom session with more in-depth information and practice.

Frequently asked questions

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 can not download the course though, thus you will need to have an internet connection to take 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.
You will have access to the course for six months.
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.
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!
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.

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, then you can select Direct bank transfer at the very end of the checkout process. You will receive an invoice instead, and you can pay by bank transfer.

Yes, you can. The course is in HTML5 format which will play on any new iOS or Android devices.
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.
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.
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.
There are no pre-requisites for this course.


Group purchase

You can make a single seat purchase through the shopping cart on Medical Device HQ using a credit card or bank transfer. Please note that, when buying for yourself, the course access is linked to the email address, and the name you enter on checkout.

For a multiple seat purchase, click the button below which will take you to the product page where you can simply enter the number of seats you require.

With a group purchase, we can grant you (or another person you assign) group leader access which enables management of your group, including both adding and removing participants, and receiving progress reports and quiz reports.

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