INTRODUCTION TO USABILITY ENGINEERING AND IEC 62366-1

ONLINE COURSE

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)
from € 399
Purchase the course access for single user:
Purchase the course access for a group of users:

Select your course plan

ONLINE

YOU ARE HERE

€ 399

Checkmark MDHQ  Average completion time​  8-16 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  6 months access to the course and instructor

ONLINE LIFETIME

€ 499

Checkmark MDHQ  Average completion time​  8-16 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ Ask the instructor

Checkmark MDHQ Lifetime access to the course and instructor

BLENDED

€ 999 ​

Checkmark MDHQ  Average completion time​  16-24 hours

Checkmark MDHQ  Total video duration​ 4.5 hours

Checkmark MDHQ  Number of quizzes​ 35

Checkmark MDHQ  Final exam​

Checkmark MDHQ  Course certificate​

Checkmark MDHQ  Ask the instructor

Checkmark MDHQ  Lifetime access to the course and instructor

Checkmark MDHQ  Printed course companion

Checkmark MDHQ  Classroom sessions (2 * 3.5 hours)

Checkmark MDHQ  Templates

IN-HOUSE TRAINING​

CONTACT US​

Tailored training to meet your company's needs

Average completion time
The average course completion time varies based on prior knowledge and individual course goals. It includes video viewing, quizzes, and final exam.
Total video duration
This is the total recorded video duration for the whole course (excludes quizzes and exam). Participants often rewatch videos for better comprehension.
Number of quizzes
This is the total number of quiz questions in the course. They are spread throughout the course, typically at the end of each lesson. They can, for example, be multiple choices, true/false, or short written answers.
Course access
Lifetime access to the online course is granted upon completion of the course and final exam within six months from enrollment. Access continues as long as the course remains available on the website without significant changes.
Final exam
The final exam consists of 30-45 randomly selected quiz questions, taken once under timed conditions, for verification of training and course certificate issuance. No pass/fail, but the score is recorded in training record.
Course certificate
Upon completion of the final exam, two course certificates are issued: 1) A social media-friendly certificate that can be easily shared on LinkedIn. 2) A PDF course certificate, including the final exam score, suitable for your training records. When attending the blended course, a course certificate covering both the online course and the classroom session is also issued.
Ask the instructor
Enrolled learners can utilize the comment fields in each lesson to ask questions, which are answered by the course creator. Please note that the course creator provides responses to questions of a generic nature and they do not substitute regular consulting assignments.
Printed course companion
The personal printed course companion serves as a comprehensive summary of the online course, condensing the key concepts into concise bullet points accompanied by relevant images and helpful flowcharts.
Classroom sessions (2 * 3.5 h)
The classroom sessions, held over two half-days (3.5 hours each), provide a highly interactive environment for applying the theory learned during the online course. Guided by an expert instructor, there are real-life case scenarios to work through and plenty of time for discussions and questions. It's an opportunity to further enhance understanding and practical skills in a collaborative setting.
Templates
Our exclusive collection of time-saving templates are designed to enhance the online course experience. These templates provide practical knowledge and assist in implementing corresponding requirements to improve operations.
€ 399
8-16 hours
4.5 hours
35
6 months access

You're here

€ 499
8-16 hours
4.5 hours
35
Lifetime access
€ 999
15-22 hours
4.5 hours
35
Lifetime access
Contact us
Tailored training to meet your company’s needs

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 receive a course certificate upon successful completion of the course.

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).

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 Direct access to standards authors

Our courses are developed by members of the standardization committees involved at both national and international levels, ensuring you receive first-hand knowledge and insights. 

You can ask our instructors questions during the online course thereby gaining exclusive up to the minute information.

Checkmark MDHQ Self-paced and bite-sized learning

Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information. This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.

medical device hq instructors - 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.

medical device hq instructors - Walter Jonas

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.

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.

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.

If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply)

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.

We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form

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

If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.

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.

Testimonials

Group purchase

If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.

If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.

It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.

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

Oops, I actually wanted to buy seats for several people. Take me to the right place.

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