ONLINE
YOU ARE HERE
€ 399
Average completion time 8-22 hours
Total video duration 4.5 hours
CPD points 16
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Digital course companion
6 months access to the course and instructor
ONLINE LIFETIME
€ 499
Average completion time 8-22 hours
Total video duration 4.5 hours
CPD points 16
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Digital course companion
Lifetime access to the course and instructor
BLENDED
€ 999
Average completion time 15-29 hours
Total video duration 4.5 hours
CPD points 23
Number of quizzes 34
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Digital course companion
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).
Become confident in planning usability engineeringThe 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.
Direct access to standards authorsOur 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.
Self-paced and bite-sized learningOur 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.
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.
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.
NOTE – The course program structure is subject to change.
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 8-22 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.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completion of the course, you are awarded 16 CPD points for the online course and 23 CPD points for the blended course.
Your course certificate will display the exact number of CPD points. Read more.
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.
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.
Choose your course options below
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.
Choose your course options below
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.
Choose your course options below
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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.