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UA3090 Usability Engineer - CPUX-F – Medical Products IEC62366

  • Usability engineer in 4 days including basic certification CPUX-F and preparation for CPUX-UT advanced level certification according to UXQB®. Also teaches all basics for the development and design of medical devices according to EN62366 / IEC 62336-1 / -2 and FDA, including usability file.
  • 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 context of use analysis, persona, conception, prototyping to usability testing + test + certificate.
  • Globally recognized certifications: The certificate “UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F)” certifies that the certificate holder is familiar with the basic terms and concepts from the field of usability and user experience in the most important areas of competence.
  • Summative & formative evaluations - usability tests & inspections:All content and practical exercises of the curriculum CPUX-UT Usability Evaluation according to UXQB (international standard for usability & UX training).
  • Usability file: The training for every 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 where in the usability file.
  • Unique:Planning, implementation and evaluation of usability evaluation with real users in the seminar and remote / unmoderated usability tests with real users and video recording.
  • Practical relevance: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 parts of the seminar.
  • UXQB®:The usability & UX expert provides all participants with the most important usability & UX methods according to the official criteria and the curriculum of the UXQB (Usability & UX Qualification Board).
  • Recognised UXQB® certificate:Certified Professional for Usability and User Experience - Foundation Level (CPUX-F). The certificate “UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F)” certifies that the certificate holder is familiar with the basic terms and concepts from the field of usability and user experience in the following areas of expertise.


   4 days

Target Group:

  • Manufacturers of medical devices
  • Product Managers medical devices
  • User interface designers
  • Software engineers 
  • Project managers
  • Quality managers
  • All persons involved in development projects, who work in and have a say in the design of medical devices.
  • Marketing

Module 1:

The human-centered design process - Human Centered Design

  • Understanding the essential elements of human-centred design
  • 6 principles of human-centered design
  • Involvment of 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) & the difference
  • Concept of usability
  • Effectiveness, efficiency & satisfaction
  • Designing & implementing 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-centered 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 usage scenarios and storyboards
  • Information architecture and navigation structure
  • Mental models, affordances, design principles
  • Style guide, user interface elements and design patterns

Practical exercise:

  • Develop low-fidelity prototype

Module 4: Design Solutions

Practical exercises:

  • Developing a low-fidelity prototype

Exam preparation CPUX-F

Module 5: Introduction of the 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:

  • Implementation of 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 subjects

Module 6: Structure & Report Usability evaluation results

Practice exercise 13 

Conducting a usability test with real users

Structure & Report usability evaluation resultsEvaluate usability tests

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

Practice exercise 14

  • 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 contents; 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

 Test and certificate "Usability Academy - Usability Engineer Medical Devices"

  • Exam: Certification "Usability Engineer Medical Devices" of the Usability Academy
  • Online test with approx. 40 questions
  • Multiple choice questions
  • Award of the 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 


1.895,- 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).