Certified Human Factors & Usability Engineering Medical devices
Enrich your career as a usability professional for medical devices
The interactive online training for professionals, with a focus on the Regulatory Human Factors & Usability Engineering process for medical devices. Option to acquire the CPUX-F certificate.
Your added value from this seminar
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Mastering global standards
Learn how to deal with internationally relevant standards such as DIN EN 62366-1 and FDA-2011-D-0469 for medical devices.
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Practical usability tests
Learn how formative and summative usability tests are carried out to improve products and prove their safety in use.
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Deriving use scenarios
Learn how to create use scenarios and how these are used in use-related risk assessments.
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Effective Reporting
Improve your reporting capabilities for a clean documentation of your usability engineering activities.
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200+
Satisfied graduates
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300+
Extensive manuscript
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16 Hours
Intensive training
Target groups for this seminar
The seminar is aimed at all those involved in the development, design and evaluation of medical technology products (both physical and digital).
- Product manager and project manager
Learn how to keep track of regulatory requirements and prepare usability documentation in line with standards. - Regulatory Affairs Manager
Gain in-depth insights into the regulatory requirements of the usability engineering process for the approval of medical devices. - Marketing Manager
Gain an overview of the usability engineering requirements and their implementation in product development in order to be able to respond optimally to your customers. - Product developer and designer
Learn how to effectively test your products formatively and summatively and reflect this knowledge back into product development. - UX/Usability expert
Deepen your knowledge of the user-centered design and evaluation of medical products. - Design engineers, electrical engineers, software developers
Integrate usability principles into technical development and improve product quality. - Consultant
Learn to build up a ready range of methods in the field of usability engineering in order to be able to optimally support various projects and technologies.
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“Thank you for walking us through the world of Usability Engineering. It was a great and educational experience.”
Christophe Van Gerwen
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“They were entertaining remote half-days. Great mix of theory and practice. The lecturers always responded to the individual topics and case studies of the participants.” *
Uli Kuchenbrod
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“Das Seminar war praxisrelevant, realitätsnah und sehr gut strukturiert und organisiert. Die sehr engagierten und kompetenten Dozenten haben sich Zeit für alle Fragen genommen.”
Sava Savchev
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“The seminar showed me once again what potential usability engineering has for innovation beyond risk mitigation.”
Uta Schadow
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“The seminar was characterized by well-founded specialist knowledge paired with high practical relevance. I would also like to emphasize the good preparation […], which made the seminar a very good fit for our company […]. I can definitely recommend the seminar to both beginners and advanced learners.” (translated)
Hendrik Homans
Seminar schedule
Day 1 Morning: Basics of usability evaluation and test planning
(09:00 to 12:00 oclock)
- Welcome, introduction and thematic introduction
- Expectations and pain points of the participants
- Basics and terms of human-centered product development (ISO 9241 family of standards)
- Terminology in usability engineering for medical devices
- Overview of relevant laws and standards for medical technology design (MDR, DIN EN ISO 14971 : 2022, IEC DIN EN 62366-1 : 2021, IEC/TR 62366-2 : 2016, DIN EN ISO 13485 : 2021)
- Human factors & usability engineering in an international context (USA FDA: FDA-2011-D-0469, China NMPA: YY/T 1474-2016, UK MHRA: Guidance Document)
- User research and context of use analyses – development of the use specification (intended use, use environment, user profiles) + exercise 1
Day 1 Afternoon: In-depth study of requirements engineering and risk assessment
(13:00 to 17:00 oclock)
- Requirements engineering – from user needs and requirements to system specifications + Exercise 2
- Development of usage scenarios and use-related risk assessment using PCA analysis + Exercise 3
Day 2 Morning: Design and evaluation of medical devices
(09:00 to 12:00 oclock)
- Recap Day 1
- Iterative design process
- Formative evaluation, exercise: heuristic evaluation
- Summative evaluation, exercise: usability test in the usability lab
Day 2 Afternoon: Usability reporting and final documentation
(13:00 to 17:00 oclock)
- Summative usability evaluations and root cause analyses + exercise 6
- Usability reporting and documentation – standard-compliant preparation of all relevant documents of the usability file
- Usability engineering of the accompanying documentation – human-centered review and design of the instructions for use
- Relevant aspects of usability engineering in the context of post-market surveillance
- Seminar wrap-up
Additional date: Preparation for the CPUX-F exam (online)
(13:00 to 17:00 oclock)
- Going through relevant exam questions
- Clarification and sharpening of curriculum understanding by the lecturer
- Q&A on all exam-relevant content covered
- Duration 2 – 4 hours (depending on the number of participants)
- Date & time will be defined with participants at the start of the seminar (approx. one week after the seminar)
Following the seminar
- Official CPUX-F* exam
*The exam takes place online. You can choose to take it at the end of the course or arrange a different date if you would like to review the material before taking the exam.
Venue and accommodation options
Venue
We conduct our in-house training courses directly at your premises.
Alternatively, the seminar can also take place in the event rooms of USE-Ing. GmbH, Zettachring 8, 70567 Stuttgart, Germany (see map).
Overnight accommodation
The B&B Hotel Stuttgart-Airport/Fair. offers overnight accommodation in the immediate vicinity.
Your instructors
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Prof. Dr.-Ing. Stefan Pfeffer
Entwicklungsingenieur und Produktgestalter
Prof. Dr.-Ing. Stefan Pfeffer, a renowned expert in usability and user experience research, shares his extensive knowledge and experience directly from the field.
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Dr. Julia Moritz
User Research Professional
Dr. Julia Moritz, a passionate expert in user research & usability engineering, will be happy to inspire you to optimize your user-centric methods and activities.
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Dr.-Ing. Benedikt Janny
Usability Engineer
Dr. Benedikt Janny, an expert in Human Factors & Usability Engineering, is committed to spreading practical knowledge and experience at every opportunity.
Certificates
Participant certificate
The USE-Ing. Academy certificate documents the acquisition of the course content and acquired knowledge upon complete participation.
CPUX-F certificate
Training according to current standards
CPUX-F certificate
The internationally recognized CPUX-F certificate represents the standard for user interface design of the International Usability & User Experience Qualification Board (UXQB).
CPUX-F forms the basis for the Essentials in UX und HCD-Management (CPUX-M) seminars and the advanced level seminars User Requirements Engineering (CPUX-UR), Designing Solutions (CPUX-DS) and Usability Testing & Evaluation (CPUX-UT). In these in-depth training courses, individual areas of activity are then dealt with in more detail.
Type of examination
You acquire the CPUX-F certificate by passing a written certification exam. The 90-minute multiple-choice exam is proctored by the relevant certification body and consists of a series of 40 multiple-choice questions. Further information on the content and the exam can be found here.
If you would like to take the certification exam after the seminar, you can choose a date and exam location that suits you from the certification provider Certible or ISQI and register for the exam yourself. Alternatively, you can simply let us organize the exam for you by informing us directly when you register.
We will be happy to take care of the organization of your exam.
Participation fee / Costs
- Register now
Inhouse Seminar
Intensive training in your company
on request
Individual adaptation of the seminar content
Examples and exercises directly on your project topics
Optimal opportunity to respond to the needs of the participant group
Ideal for a sustainable usability engineering strategy for the entire team
Please note that only one discount (excluding discounts on examination fees) can be claimed per participant.
Frequently Asked Questions
Do the participants receive certificates or other evidence?
Yes, all participants receive a certificate of attendance at the end of the seminar, which confirms their newly acquired knowledge and skills. For many seminars, you have the option of taking an additional certification exam to certify the knowledge and skills you have acquired to international standards.
Are there online options for the seminars?
Yes, we offer both face-to-face seminars and online alternatives. The online seminars are interactive and offer the opportunity to communicate with the lecturers and other participants in real time.
Problems with the Certible voucher for exam registration?
Make sure that you have selected the correct exam and have entered or copied the code correctly (spaces). If you still have problems booking the exam, the USE-Ing. Academy team will be happy to help you.
What does the CPUX certificate include?
A CPUX (Certified Professional for Usability and User Experience) certificate confirms comprehensive knowledge and skills in the areas of usability and user experience. The certificate is internationally recognized and certified by the UXQB (International Usability and User Experience Qualification Board). There are different levels of the CPUX certificate.
What can I expect from the USE-Ing. Academy seminars?
The USE-Ing. Academy seminars offer in-depth training in the areas of usability engineering and human factors. Participants learn how to effectively integrate human-centered design approaches into product development. This includes analysis, ideation, design and evaluation of user interfaces for technical products.
What do I do if I am unfortunately unable to attend my booked seminar?
We will always try to provide you with the best possible support in such situations. In such cases, the seminar ticket can be transferred to another person. Otherwise, please contact our Academy team to find an appropriate solution.
What are the advantages of attending a USE-Ing. Academy seminar?
Participants benefit from the expertise of leading usability engineers and designers, learn industry-specific best practices and gain insights into the latest technologies and standards. Participation also provides an excellent opportunity to network with industry peers.
How can I ensure that the seminar meets my specific needs?
We recommend that you check the seminar program carefully before registering and contact our USE-Ing. academy consultants if necessary. They will be happy to help you find the right seminar for your professional requirements.
How do I register for a seminar?
Simply register via our website. Select the seminar you want, fill out the registration form and send it off. We will then get back to you as soon as possible with the seminar confirmation. If you have any further questions, you can contact our Academy team at any time.
Your question was not answered?
Our Seminar Management Dr.-Ing. Marcus Jenke will be happy to answer your questions.