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UA3100 Usability & UX Experte Medical Products IEC 62366 ONLINE - EUROPE

  • Usability & UX Expert – a five day course. Includes basic CPUX-F certification and preparation for the CPUX-UT advanced level certification according to UXQB® as well as all basics for the development and design of medical devices according to EN62366 / IEC 62336-1 / -2 and FDA, including 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, to use context analysis, persona, conception, prototyping up to the usability testing + test + certificate
  • Globally 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 and terminology of the most important areas of expertise  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 will show you which work results can be found where in the usability file.
  • Unique: Planning, execution and evaluation of usability evaluation with real users in the seminar and remotely / unmoderated usability tests with real users and video recording.
  • Proximity to practice:The focus of the seminar is on practical exercises. There are extensive practical exercises in the areas of touch design, tablet and mobile for medical devices for all concepts of the CPUX seminar parts.
  • 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 most important areas of expertise of usability and user experience.
  • UX Training according to International Usability and User Experience Board (UXQB) inkl. exercises
  • Exam preparation training for „UXQB® CPUX-F certification  1 454x340 
  • LIVE ONLINE Training with V-Classroom-XL - Video Audio - ONLINE REALTIME WHITEBOARD - eLearning Portal - Virtual Classroom
  • 5 days online V-Classroom-XL training & workshop + test + certificate
  • 40 hours full of UX methods, concepts
  • 10 Participants maximum - NO mass training - much time for individual questions


5 days

Optional: CPUX-F exam (Please mention upon registration if you would like to opt for the exam.)*

Target Group:

  • Manufacturer of medical devices
  • Product Manager medical devices
  • User Interface Designer
  • Software Engineer
  • 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
  • The difference between usability & user experience
  • Principles of dialogue design
  • Intuitivity and affordance
  • Standards and guidelines

Practical exercises:

  • Differentiate between usability and user experience by using practical examples

Understanding and Specifying Use Contexts:

  • User groups, user group profiles and personas
  • Primary users, secondary users, indirect users
  • Current scenarios versus use scenarios (target scenarios)
  • Interviewing and observation techniques

Practical exercises:

  • Reference to the usability file
  • Use context analysis

Usability Testing

  • Types of usability tests
  • Selecting and defining usability test tasks
  • Preparing and running usability tests
  • Documenting and communicating usability test results
  • Inspections and user surveys
  • Types of inspections
  • Inspection criteria
  • Types of user surveys
  • Questionnaire selection and design

Practical exercise:

  • Developing test tasks for a crowd usability test for an app or user software, e.g. rapid user tests
  • Defining the screening criteria for usability tests
  • Preparing documents for a remote / crowd usability test
  • Evaluating videos of test persons

Day 2: Usability Engineering & Usability Files:

Specifying User Requirements

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

Practical exercises:

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

Specifying 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 exercises:

  • Describing use scenarios
  • Developing storyboards and workflows
  • Harmonizing design via wireframes
  • Iterative user centered design & SCRUM
  • Development of 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
  • Specifying requirements for usability
  • Methods to verify and validate usability
  • Creating test plans as well as executing and documenting tests
  • Arranging content; in which file (usability file, risk management file, quality management manual, etc.) should which results be documented and how should the files be linked?

Further 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 aspects

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

  • Differentiating the goals of a user survey
  • Selecting the type of user survey
  • Qualitative user survey
  • Quantitative user survey
  • Planning a user survey
  • Recruiting survey participants
  • Selecting or creating a questionnaire
  • Evaluating survey results
  • Presenting survey results
  • Typical problems with questions

Day 4: Usability Testing

Usability Testing

Test Preparation

  • Creating a test plan
  • Creating a test script
  • Recruiting 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
  • Interpreting and evaluating 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, smart phones, 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

CPUX-F Certification exam: 300,- plus VAT

Seminar including examination & certificate of Usability Academy

Event Information

Event Date 06-02-2023
Event End Date 10-02-2023
Capacity 10
Individual Price 2.395,00 €
Location Central Europe CET UTC +2 Berlin
We are no longer accepting registration for this event