UA3100 Usability & UX Expert CPUX medical products IEC62366 certificate course

  • Usability & UX expert in 5 days incl. basic certification CPUX-F and preparation for CPUX-UT Advanced Level certification according to UXQB® and basics for the development and design of medical devices according to EN62366 / IEC 62336-1 / -2 and FDA, incl. Suitability for use
  • IEC 62366-1 / -2: The seminar teaches all important concepts for the development and design of medical devices according to EN62366 / IEC 62336. From the basics of ISO 9241, through use context analysis, persona, conception, prototyping up to the usability testing + test + certificate
  • Global Recognized Certifications: The UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F) certifies that the certificate holder is familiar with the basic concepts in the field of usability and user experience
  • Summative & Formative Evaluations: All content and practical exercises of the curriculum CPUX-UT Usability Evaluation according to UXQB (international standard for usability & UX training).
  • Usability File: Training for any UX Professional in medical device development who wants to implement the latest changes in IEC 62336-1 / -2 and FDA. The seminar shows you which work results can be found in the usability file and even where.
  • Unique: Planning, execution of an usability evaluation with real users in the seminar and remote / unmoderated usability tests with real users and video recording.
  • Proximity to practice: The focus of the seminar is on practical exercises. For all concepts of the CPUX seminar parts there are extensive practical exercises in the areas of touch design, tablet and mobile for medical devices.
  • UXQB®: The course teaches the most important Usability & UX methods according to the official criteria and syllabus of the UXQB (Usability & UX Qualification Board).
  • Approved UXQB® Certificate: Certified Professional for Usability and User Experience - Foundation Level (CPUX-F). The "UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F)" certificate certifies that the certificate holder is familiar with the basic terms and concepts of the field of Usability and User Experience.


5 days

Option: CPUX-F exam (If you want to take the exam, please mention when registering)*

Target Group:

  • Manufacturer of medical devices
  • Product Manager Medical Products
  • User Interface Designer
  • Software engineers
  • Project Manager
  • Quality manager
  • All those who are involved in development projects who collaborate and influence the design of medical devices
  • Marketing

Seminar Content:

Day 1: Basics of Usability & UX - CPUX-F Curriculum (UXQB) & Reference to IEC 62366

Day 2: Usability Engineering & Usability Record - IEC 62366-1 / -2 REVISION

Day 3: CPUX-UT to UXQB Usability Testing - Formative & Summative Evaluation IEC 62366

Day 4: Usability Inspections and User Surveys & Reference to IEC 62366

Day 5: Interaction Specification, Style Guides & Prototyping & Certification Exam

Day 1: Basics of Usability & UX

Usability principles and guidelines:

  • Overview of Usability, User Experience, UCD User Centered Design, ISO 9241
  • Basics of User-Centered Design ISO 9241-210
  • Most important standards and guidelines ISO 9241-11 / 110/12
  • Usability & User Experience the difference
  • Principles of Dialogue Design
  • Intuitivity and Affordance
  • Standards and guidelines

Practical exercise:

  • Difference between Usability & User Experience, practical examples

Understand and specify use contextes:

  • User Groups, User Group Profiles and Personas
  • Primary users, Secondary users, Indirect users
  • Current scenarios versus use scenarios (target scenarios)
  • Interview and observation techniques

Practical exercise:

  • Reference to the usability file
  • Use context analysis

Usability testing

  • Types of usability tests
  • Select and define usability test tasks
  • Prepare and run usability tests
  • Documention and communication of usability test results
  • Inspections and user surveys
  • Types of inspections
  • Inspection criteria
  • Types of user surveys
  • Questionnaire design

Practical exercise:

  • Developing test tasks for a crowd usability test for an app or user software, e.g. Rapid user tests
  • Working out the screening criteria for usability tests
  • Preparation of documents for a remote / crowd usability test
  • Evaluation of test videos of probands

Day 2: Usability Engineering & Usability Files:

Specifying the user requirements

  • User needs versus user requirements
  • User requirements as a subset of stakeholder requirements

Practical exercise:

  • Identify user needs - what does the user really need?
  • Derivation of user requirements
  • How to reference to the usability file

Specify the interaction

  • Task modeling as a basis for task-appropriate interaction
  • Interaction specification with user scenarios and storyboards
  • Usage objects, information architecture and navigation
  • Basic Principles of 'Good UX Design', Golden Rules
  • Perception Psychology - Mental Models, Affordances, Gestalt Principles
  • Design and design rules

Practical exercise:

  • Describing use scenarios
  • Develop storyboards and workflows
  • Harmonize design via wireframes
  • Iterative User Centered Design & SCRUM
  • Develop detailed use cases
  • Development of interactive prototypes and documentation in the usability file
  • Exercise with Axure

Process management and use of methods

  • Process roles
  • Work products in usability engineering

Usability File according to IEC 62366

  • Structuring a usability file
  • Specify requirements for usability
  • Verification and validation method of usability
  • Preparation of test plans and execution and documentation of tests
  • Arrange content; in which file (usability file, risk management file, quality management manual, etc.) should which results be documented and how should the files are linked?

Other Aspects - Differences in IEC 62366 / FDA Conformity / Interaction with ISO 14971

  • The IEC 62366 and the usability-oriented development process
  • Interaction of IEC 62366 and risk management according to ISO 14971
  • Structure of a usability file, documentation structure
  • Method of testing usability: E.g. Inspection processes (such as Style and Design Guidelines, ISO 9241, Heuristics), usability testing, and quantitative and qualitative user surveys
  • Documentation of test specifications and test results
  • FDA conformity issues

Day 3: Inspection-based evaluation

Usability evaluation (inspection)

Evaluation types (inspection types)

  • Heuristic evaluation
  • Expert Review
  • Review
  • Cognitive walkthrough
  • Persona based review

Typical problems

  • inspection criteria
  • heuristics
  • design rules
  • user requirements
  • Inspection without inspection criteria

User survey

  • Differentiate the goals of a user survey
  • Select the type of user survey
  • Qualitative user survey
  • Quantitative user survey
  • Planning a user survey
  • Recruit survey participants
  • Select or create a questionnaire
  • Evaluate survey results
  • Present survey results
  • Typical problems with questions

Day 4: Usability Testing

Usability Testing

Test preparation

  • Create a test plan
  • Create a test script
  • Recruit test participants

Typical problems

  • Test task creation
  • Non-Disclosure Agreement

Performing usability tests

  • Preparation of the test
  • briefing
  • Pre-test interview
  • test moderation
  • Post-test interview
  • De-briefing
  • Typical problems

Preparation of test results and communication

  • Psychological aspects of the test result mediation
  • Interpret and evaluate test results
  • Usability test report
  • KJ method, affinity diagrams
  • video analysis
  • Management Summary

Variants of usability testing

  • Discount usability test
  • Remote Usability Test
  • Unattended usability test
  • Crowd Usability Testing
  • Quantitative usability evaluation
  • Eye-tracking
  • RITE (Rapid Iterative Testing and Evaluation)
  • International Testing
  • Usability Testing beyond Desktop Applications: Mobile Phones, Ticket Machines, Televisions, Smartphones, Tablets

Day 5: Interaction specification & UX design:

UserFlow, UseCase & Wireframe IxD - UX Design

  • Processes and sequences for a task-oriented design
  • Iterative development of UserFlow, UseCase & Wireframe
  • Validation of the concept ideas
  • Exercise: UserFlow, UseCase, Wireframe

Basics of good design

  • Basic Principles of 'Good UX Design', Golden Rules
  • Perception Psychology - Mental Models, Affordances, Design Principles
  • Design and design rules
  • Basics of interaction design and graphic design
  • Innovative UX design

Interaction design IxD - UX design

  • Overview of interaction elements and use of it
  • Basic rules of user experience design


  • Introduction to prototyping in the context of usability engineering
  • Overview of prototype types, applications and test times
  • Low-fidelity prototyping
  • Exercise: 'paper prototyping' and / or tool-based prototyping

Prototyping with Axure

  • Prototyping in the context of usability engineering
  • Overview of different prototypes, applications and testing
  • Low-fidelity prototyping
  • Exercise: 'Paper Prototyping'
  • High-fidelity prototyping
  • Exercise: 'Creating interactive prototypes (Axure)'

Test and Certificate "Usability Academy - Usability & UX Expert Medical Devices"

  • Exam: Certification Usability & UX Expert
  • Online test with 40 questions
  • Multiple choice questions
  • Usability Academy certificate


*Information for the CPUX-F exam:

  • The exam can take place remotely from home (75 minutes) 
  • You need an undisturbed (home) workstation and a computer with webcam and microphone, stable internet connection and either Chrome, Firefox or Opera Browser.
  • You are free to choose the date. It could be useful to prepare 1-3 days. Some use a weekend in between for intensive study.
  • Registration and payment can be made via the Usability Academy or directly with the Exam Organization Certible or ISQI 


2.395,- Euro plus VAT without examination 

300,- Euro plus VAT CPUX-F certification exam 

(240,- Euro plus VAT for members of the German UPA, 150,- Euro plus VAT for students).


Recommended prerequisite: None - Also suitable for beginners  




Dates Usability Expert MED