Certified Human Factors & Usability Engineering Medical Devices (Online)

In the interactive remote training “Certified Human Factors & Usability Engineer Medical Devices” on four consecutive afternoons from 1:00pm to 5:00pm you will learn the human-centred topics that are relevant to Medical Device Development and Approval from a regulatory point of view.  With the aid of practical examples from the field of medical technology, understanding of theoretical context will be deepened and enhanced. Concretely, the course curriculum includes the following:

• Context of Use analysis (intended use, use environment, user profiles)
• User requirement engineering (From User Needs and Requirements to System specifications)
• Development of Usability Scenarios and use-related risk assessment
• Creation of conform Usability Engineering Documentation (usability engineering files / human factors validation reports) according to DIN EN 62366-1 and FDA-2011-D-0469
• Preparation, organization and execution of formative and summative usability tests and evaluations (verifications, validations)
• Acquisition of acceptance criteria and execution of root cause analyses
• Usability reporting and traceability
• Connecting the usability engineering process with risk management and technical development
• Human factors & usability engineering in international context USA, China, UK

Our dedicated services:

• You will receive a detailed seminar transcript – your personal Usability Engineering File Playbook.
• Any required utensils for practical exercises will be mailed to you in advance.
• In case of any questions, until 7 days after graduation, our experts will be available to you via phone and email.
• Additional date for exam preparation available to all CPUX-F candidates.

After successful participation, you will receive a participation certificate, documenting the curriculum and content knowledge gained. In addition, as official training provider of UXQB®, USE-Ing enables participants to obtain the internationally recognized certificate “Certified Professional for Usability and User Experience – Foundation Level (CPUX-F)” as part of the seminar. The certificate attests that the certificate holder is familiar with basic terms and concepts of usability and user experience, and is obtained during a 90 minutes multiple choice questions exam. If this is requested, please note that there will be a surcharge of 300,- Euro  for the UXQB® certifiable exam “Certified Professional for Usability and User Experience – Foundation Level (CPUX-F) added to the regular cost of the seminar. Further information about the certificate and exam may be found here.

This training is designed for everyone working in the field of development, design, or evaluation of medical devices, either physical or digital.

As Product Manager, Regulatory Affairs Manager, Project Leader, or Marketing Manager you will gain an overview of regulatory requirements and will be in position to create conform usability documentation in line with medical devices approval.

As Product Developer, Designer, UX / Usability Expert, Electrical Engineer, Software Developer or Consultant, you will learn how to formatively and summatively test technical products with users and how to feed this knowledge back to product development.

The number of seminar participants is limited to 15 people to ensure optimal support and knowledge transfer. For a constructive and motivated group collaboration, we always strive for a most heterogeneous group set up and will select participants accordingly.

Your trainers come with years of experience in academical research and teachings, as well as in design and advisory withihn the field of industrial technology. Looking forward to meeting you is:

Prof. Dr.-Ing. Stefan Pfeffer (UX / Usability – Professional, Development Engineer and Product Designer)

Please find below a detailed schedule of the course.

Topics Day 1 (1:00pm to 5:00pm)

• Welcome, personal introduction and introduction of the subject matter
• Expectations and pain points of the participants
• Foundations and Content of medical devices development (ISO 9241 standards)
• Concepts in usability engineering for medical devices
• Overview of relevant laws and standards in the field of medical devices 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 international context (USA FDA: FDA-2011-D-0469, China NMPA: YY/T 1474-2016, UK MHRA: guidance document)
• User Research and user requirement engineering – evaluation of use specification (intended use, use environment, user profiles) + exercise 1

Topics Day 2 (1:00pm to 5:00pm)

• Recap Day 1
• Requirements engineering – User needs to requirements to system specifications + exercise 2
• Evaluation of use scenarios and use-related risk assessment via PCA-analysis + exercise 3

Topics Day 3 (1:00pm to 5:00pm)

• Recap Day 2
• Technical user interface design for medical devices and equipment (design principles, heuristics, prototyping) + exercise 4
• Formative and summative usability evaluationen (from verification to validation) – organization and execution + exercise 5

Topics Day 4 (1:00pm to 5:00pm)

• Recap Day 3
• Summative usability evaluationen and root cause analysis + exercise 6
• Usability reporting and documentation – standard-compliant creation of all relevant documents in the Usability File.
• Usability engineering of the accompanying documentation – human-centred exam and instruction manual design (Instructions for Use)
• Relevant aspects of the usability engineering in terms of post-market surveillance
• Course wrap-up

Additional date for CPUX-F  exam preparations (Online)

• Looking at relevant exam questions
• Enhancing and deepening the understanding of the curriculum material with aid of the trainer
• Q&A for all applicable exam-related content
• Duration 2 – 4 hours (depending on number of participants)
• Date & time will be determined at the beginning of the course with the participants (approximately one week after the course).

The regular cost for the four day intensive course “Certified Human Factors & Usability Engineer Medical Devices” accumulate to 1.290,00 Euro plus VAT or 1.535,10 Euro incl. VAT. If requested, you may also book the UXQB® Certification Exam „Certified Professional for Usability and User Experience – Foundation Level (CPUX-F)“ at an additional cost of 300,- Euro (150,- Euro for students) in addition to the regular seminar cost. Further information about the certification and the exam may be found here.

Discounts may be offered for the following circumstances:

• 10 % Early bird discount applicable for binding registrations until 2 months prior to course start
• 20 % from the second attendee of a company onwards
• 30 % for active customers of USE-Ing.

Kindly note that only one discount may be applied per person.

Our course manager Christiane Wranja is happy to answer them.