Learn about the essentials of usability engineering for medical devices with Dr. Michaela Kauer-Franz, a TÜV Rheinland certified medical devices usability expert.

The course covers the core steps of the usability engineering process. After learning the theoretical steps during the online course, you will be able to put them in to practice during the classroom sessions. You will write a use specification, work towards the first formative test, plan a summative study and conduct a root cause analysis on the errors. This will provide you with the hands on experience and confidence to get you going in usability engineering.

Blended course
Course length
16-24 hours
Next classroom sessions
31 May -1 Jun
1PM-4:30PM CET
Course fee
(per person)

Course description

This course consists of two parts:

1. The Introduction to Usability Engineering and IEC 62366-1 online course
2. Two half-day live virtual classroom sessions facilitated by an instructor

First, you complete the Introduction to Usability Engineering and IEC 62366-1 online course. It covers topics such as 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.

You can start the online course immediately and have access to it for 6 months, but you must successfully complete the final exam prior to the classroom sessions. If you have already completed the online course, you can register for the classroom sessions only.

The unique, highly interactive live virtual classroom sessions are facilitated by Dr Michaela Kauer-Franz or Dr Jonas Walter. During the sessions, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn first hand from an industry expert.

A printed course companion is included, as well as time-saving templates on how to implement design control effectively and efficiently.

We recommend this course to those who are working in product management, such as R&D and QA engineers, product and application specialists, and product owners.

Want to know more about our blended courses? Watch the video below.

Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions afterwards.

The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.

The classroom sessions are highly interactive and focuses on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions.

The instructors for the live virtual classes

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.

Walter Jonas Usability Engineering course instructor

Dr. Jonas Walter is the Lead Medical Usability Engineer at Custom Medical, an award-winning company that designs user interfaces for medical devices. (Awards include the Red Dot Winner Interface Design Award and nominated for the UX Design Award). He is the internal and external reference for complex method design and medical regulatory documentation, both under IEC 62366-1 (EU) and FDA (US) regulation for all classes of medical devices.

To date, Dr. Jonas Walter has developed class 3 surgical instruments, IVDs, nephrological and dental medical devices. He is able to apply his valuable usability engineering experience in his role of trainer and consultant to professionals within the medical device industry.

Benefits for you

Checkmark MDHQ Understand how to design and make a safe and intuitive device

In the medical device industry, the focus of all standards is on safety and that makes perfect sense. But in this course, we will talk about ways to test the safety of use of your device AND find out, if you have built something that your users will love to use.

Checkmark MDHQ Blended learning combines the best of both worlds 

You get to learn the theory at your own pace, during the online course, before applying the theory to practice with the guidance of an industry expert. You can get started on the online course right after registration and invoicing.

Checkmark MDHQ Get feedback from an expert

This is your chance to get feedback directly from an expert. During the blended course, we will work on one joint example and walk our way through the usability engineering process. Every step will be discussed and your questions will be answered. This will help you to be more confident in applying the usability engineering process when back at work.

Checkmark MDHQ Course certificate

Auditors may look for evidence that you are competent in usability engineering. You will receive a course certificate after the successful completion of the course, which you can show the auditors if they ask.

Course structure


Online course

The online course comprises a mixture of pre-recorded videos, quizzes, and a final exam. You have the access to the online course for 6 months. It is self-paced and flexible in that you can start, stop, and repeat as much as you like. When you have finished the online course, you will be taking the final exam.

The Introduction to Usability Engineering and IEC 62366-1 online course consists of 15 lessons which are outlined below.

  • 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 here 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

Classroom sessions

You will attend these two half-day live virtual instructor-led classroom sessions via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real-life case scenarios to work through, and plenty of time for discussions and questions.

The live virtual classes will cover the whole usability engineering process via examples and templates which you will learn how to use effectively.

The maximum number of people in a classroom session is 8.

Included is a printed course companion and the following time-saving templates:

  • Usability Engineering File
  • Use Specification
  • User Interface Evaluation Plan
  • Test Report

Frequently asked questions

The blended course consists of two parts: the online course and two half-day live virtual classroom sessions.

The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The live virtual classroom sessions are virtual face-to-face sessions where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions.

The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 8-16 hours to finish on average.

You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like. 

The two half-day live virtual classroom sessions, take approximately 7 hours in total.

You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.

After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.

If you buy more 3 or more seats for one person, we do. Use the contact form to request a quote for 3 or more participants. Please note, if there are more than 5 people from your organisation that should take the course, consider arranging an in-house course. The price will be lower, and the course can be customised to your needs.
You will have access to the online course for six months.
The maximum number of participants for the live virtual classroom session is 8.

There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom sessions. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.

If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again.

If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.

You will need to retake the final exam by 3pm CET the day before the first classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom sessions.

There are no pre-requisites for this course.
Dr. Michaela Kauer-Franz is TÜV Rheinland certified medical devices usability expert. She works in the German standardization committee for Ergonomics, Usability, and User Experience and has extensive knowledge as an usability engineer. In 2013 she founded the usability engineering company Custom Interactions and is heading the medical branch Custom Medical since 2017. Besides this, she is a lecturer for the design of medical and critical user interfaces at the Technische Universität Darmstadt.

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.

Would you prefer a course held on your premises?

We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

Register for a course

If you are already prepared to take a course, you can register for one of our upcoming blended courses. You’ll have 24 hours to cancel your reservation in case you can’t come.

Still haven’t decided?
Get in touch with us and get more information:

IMPORTANT – The course will be associated with the account that the purchase is made from. Are you taking the course or is someone else?