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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

Module 1:

The human-centered design process - Human Centered Design

  • Understanding of the essential elements of human-centred design
  • 6 principles of human-centered design
  • Involve users
  • Iteration based on frequent usability evaluation
  • Addressing the entire user experience
  • Agile development and Lean UX
  • Maturity levels of usability maturity

Practical exercise:

  • Classification of usability maturity

Basic Concepts – Usability & User Experience

  • Usability & User Experience (UX) & what is the difference
  • Concept of usability
  • Effectiveness, efficiency & satisfaction
  • Design & implement user experience
  • Goal, user interface, dialogue and interactive system
  • Accessibility
  • Essential contents of ISO 9241
  • Responsibilities of a user experience professional

Practical exercise:

  • Differentiate usability & user experience using practical examples (IOS / Android / Windows Mobile)

Exam preparation CPUX-F

Module 2:

Planning the human-centered design process:

  • work results and methods
  • Human-centric quality goals

Understanding and specifying the context of use:

  • Elements of the context of use
  • Task models & goals
  • User groups, user group profiles and persona
  • Primary users, secondary users, indirect users
  • Actual scenarios versus usage scenarios (target scenarios)
  • Interview and observation techniques
  • User journey map

Practical exercise:

  • Prepare and conduct interview
  • Description of context of use after brainstorming

Usability Tests & Usability Evaluation I

  • Types of usability tests
  • Select and formulate usability test tasks
  • Prepare and conduct usability tests
  • Document and communicate usability test results
  • Inspections and user surveys
  • types of inspection
  • inspection criteria
  • user survey

Practical exercise:

  • The trainer moderates a test session. One participant is the test participant.
  • Evaluation a website using heuristic evaluation

Exam preparation CPUX-F

Module 3: Specifying User Requirements

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

Practical exercise:

  • Derive user requirements

Design solutions - Specifying the interaction

  • Task modeling as a basis for interactions which are suitable for the tasks
  • Interaction specification with use scenarios and storyboards
  • Information architecture and navigation structure
  • Mental models, affordances, gestalt principles
  • Style guide, user interface elements and design patterns

Practical exercise:

  • Develop low-fidelity prototype

Module 4: Design solutions - Specifying the interaction II

Practical exercises:

  • Developing a low-fidelity prototype

Module 5: Introduction into usability evaluation CPUX-UT

Introduction into usability evaluation CPUX-UT

  • Selection of evaluation methods

Usability Inspection & Heuristic Evaluation

  • Getting to know the most important usability evaluation methods
  • heuristic evaluation
  • Cognitive Walkthrough
  • Expert Review
  • Classification of the evaluation methods in the human centered design process / usability engineering process
  • Inspection criteria - Nielsen Heuristics, Interaction principles ISO 9241-110
  • process of an inspection

practice exercise:

  • Conduct a heuristic evaluation with dialogue principles

Plan and conduct usability tests

  • Variants of usability tests
  • Prepare a usability test
  • Carrying out a usability test
  • Recruitment of test participants

Module 6:

Practice exercise

Conduct a usability test with real users

Structure & Report Usability evaluation results

  • Evaluate usability tests
  • Create evaluation report
  • Implementation of a KJ workshop
  • report findings
  • Prioritize and categorize findings

Practice exercise

  • Conduct a KJ workshop

Module 7: Usability File Medical Product

Basics for the development and design of medical products according to EN62366 / IEC 62336-1 / -2 and FDA, including usability file.

The usability file according to IEC 62366

  • Structuring of the usability file
  • Specify serviceability requirements
  • Procedures for verification and validation of usability
  • Creation of usability test plans and implementation and documentation of usability tests
  • classify content; in which file (usability file, risk management file, quality management manual, etc.) which results should be documented and how 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
  • Procedures for testing usability: including inspection procedures (e.g. checks against style and design guidelines, ISO 9241, heuristics), participatory observation (usability testing) and quantitative and qualitative user surveys
  • Documentation of test specifications and test results
  • FDA compliance aspect

Module 8: Contextual Inquiry & User requirements

Analysis - context of use analysis

  • Plan and conduct context of use analysis
  • Collect and document context of use information
  • design thinking
  • problem space and solution space
  • identify hazard related secnarios

practice exercise:

  • Document context of use information
  • Create an interview checklist
  • conduct interviews
  • Develop and describe personas
  • Create environment model
  • information model
  • Create goal catalog
  • Document task objects
  • Derive and formulate scenario as is
  • Document hazard related scenarios

Specification - User Needs & User Requirements

  • Identify user needs
  • Derive user requirements from needs and structure them
  • Consolidate user requirements
  • Work products and roles
  • Design thinking and human centered design
  • Brainstorming to generate ideas

practice exercise

  • Identify needs in the context of use

Module 9: Create Design Solutions

Specifying the interaction

  • Task modeling as a basis for task-oriented interaction
  • Interaction specification with use scenarios and storyboards
  • Interaction specification based on user-system interaction
  • Task-objects, information architecture and navigation
  • Basic principles of 'Good UX Design', Golden Rules
  • Perceptual psychology - Mental models, affordances, gestalt principles
  • Creation and design rules

Practical exercise:

  • Formulate usage scenarios
  • Developing storyboards and workflows
  • Harmonization of the design via wireframes
  • Iterative user centered design & SCRUM
  • Developing the detailed use cases
  • Development of interactive prototypes and their documentation for the usability file
  • Exercise with Axure

Module 10: Create Design Solutions II

practice exercise

Build a high-fidelity prototype

Develop a prototype with AXURE or FIGMA

Test AXURE / FIGMA prototype with others

Usability Academy certification

  • Exam Usability & UX Expert

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