Certified Human Factors & Usability Engineering Medical Devices

Your benefits from this seminar

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  Mastering global Standards

  Learn how to deal with internationally relevant standards such as IEC 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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  Derive Usa Scenarios

  Learn how to create usage scenarios and how these are used in use-related risk assessments.

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  Improve your reporting capabilities for a clean documentation of your usability engineering activities.

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  250+ Graduates

  Satisfied graduates

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  300+ Playbook

  Extensive manuscript

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  16 Hours

  Intensive training

Target groups for this seminar

• 

  “Thank you for walking us through the world of Usability Engineering. It was a great and educational experience.”

  

  Christophe Van Gerwen

  Product M&I Lead

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  “Es waren kurzweilige Remote- Halbtage. Prima Mischung aus Theorie und Praxis. Die Dozenten sind auch immer wieder auf die individuellen Themen und Case Studies der Teilnehmer eingegangen.”

  

  Uli Kuchenbrod

  Leiter der Entwicklung Medizinprodukte

• 

  “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

  Innovation Manager

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  “The seminar showed me once again what potential usability engineering has for innovation beyond risk mitigation.”

  

  Uta Schadow

  Principal Customer Experience Researcher

Seminar schedule

• Day 1: Basics of usability evaluation and test planning

  (13:00 bis 17:00 Uhr)

  • 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 2: Deepening in requirements engineering and risk assessment

  (13:00 bis 17:00 Uhr)

  • Recap Day 1
  • Requirements engineering – from user needs and requirements to system specifications + Exercise 2
  • Development of usage scenarios and use-related risk assessment by means of PCA analysis + Exercise 3

• Day 3: Design and evaluation of medical devices

  (13:00 bis 17:00 Uhr)

  • Recap Day 2
  • Technical user interface design for medical products and devices (design principles, heuristics, prototyping) + Exercise 4
  • Formative and summative usability evaluations (from verification to validation) – organization and implementation + Exercise 5

• Day 4: Usability reporting and final documentation

  (13:00 bis 17:00 Uhr)

  • Recap Day 3
  • 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 testing 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 bis 17:00 Uhr)

  • 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 exam CPUX-F*

  *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.

Your instructors

• 

  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.

• 

  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.

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  Included - Book now
• 

  CPUX-F certificate

  Training according to current standards

  Offical Curriculum CPUX-F

  Terms of participation

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  Book now with certificate

Participation fee / Costs

• Online Seminar

  Four-day intensive training course

  1.290,00 €

  Plus VAT

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  Add options

  Certificate - CPUX-F (Theory):+300,00 €

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  • 10% early bird discount for binding registration up to 2 months before the start of the seminar (examination fee excluded)
  • 20% discount from the second participant of a company (examination fee excluded)
  • 30% discount for active customers of USE-Ing. (examination fee excluded)
  • 50% discount for students up to the age of 30 (examination fee excluded)
  • 150 € discount on examination fee for students
  Register now

• Inhouse Seminar

  Intensive training in your company

  on request

  • Individuelle Anpassung der Seminarinhalte
  • Beispiele und Übungen direkt an Ihren Projektthemen
  • Optimale Möglichkeit auf die Bedürfnisse der Teilnehmergruppe einzugehen
  • Ideal für eine nachhalte Usability Engineering Strategie für das gesamte Team
  Register now

Frequently Asked Questions

• 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.

• 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.

• 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.

• 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, our USE-Ing. Academy team will be happy to help you.

• 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.

• 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 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.