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

Seminar Content:

Module 1: Basics of usability & UX - CPUX-F curriculum (UXQB) & reference to IEC 62366

Module 2: Usability engineering & usability file - IEC 62366-1 / -2 NEW VERSION - FDA

Module 3: CPUX-UT according to UXQB usability inspections and user surveys & reference to IEC 62366

Module 4: CPUX-UT according to UXQB usability testing - formative & summative evaluation IEC 62366

Module 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 / 110/112/161
  • Usability & user experience - the difference
  • Principles of dialogue design ISO 9241-110
  • Intuitiveness and Affordance - Basics of Good Design
  • Standards and guidelines

Practical exercises:

  • Differentiating between usability and user experience with the help of practical examples

Understanding and specifying the context of use: 

  • User groups, user group profiles and personas
  • Primary users, secondary users, indirect users
  • Actual scenarios versus usage scenarios (target scenarios)
  • Interview and observation techniques

Practical exercises:

  • Reference to the usability file
  • Usage context analysis

Usability Tests

  • Types of usability tests
  • Selecting and formulating usability test tasks
  • Preparing and carrying out usability tests
  • Documenting and communicating usability test results
  • Inspections and user surveys
  • Types of inspection
  • Inspection criteria
  • Types of user survey
  • Selection and design of questionnaires

Practical exercises:

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

Module 2: Usability Engineering & Usability File:

Specifying usage requirements

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

Practical exercises: 

  • Understanding user needs – what does the user really need?
  • Deriving usage requirements
  • Reference to the usability file

Specifying the Interaction

  • Task modelling as a basis for task-appropriate interaction
  • Interaction specification with usage scenarios and storyboards
  • Objects of use, information architecture and navigation
  • Basic principles of 'Good UX Design', Golden Rules
  • Perceptual Psychology - Mental models, affordances, design principles
  • Design and design rules

Practical exercises: 

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

Process management and use of methods 

  • Process roles
  • Work products in usability engineering

The usability file according to IEC 62366

  • Structuring the usability file
  • Specifying requirements for usability
  • Procedures for verifying and validating usability
  • Creation of test plans, and execution and documentation of tests
  • Classifying 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

Other aspects - Differences in IEC 62366 / FDA conformity / interaction with ISO 14971 

  • IEC 62366 and the usability-oriented development process
  • Interaction between IEC 62366 and risk management according to ISO 14971
  • Structure of a usability file, documentation structure
  • Procedure for checking usability: among others inspection procedures (e.g. checking against style and design guidelines, ISO 9241, heuristics), participating observation (usability testing) and quantitative and qualitative user surveys
  • Documentation of test specifications and test results
  • FDA conformity aspect

Module 3: Inspection-based evaluation

Evaluation types (inspection types) 

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

Typical problems

  • Inspection criteria
  • Heuristics
  • Design rules
  • Usage requirements
  • Inspection without inspection criteria

User survey

  • Distinguishing 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 in questions

Practical exercises:

  • Determining inspection criteria
  • Conducting an inspection

Module 4: Usability Test

Test preparation

  • Creating a test plan
  • Creating a test script
  • Recruiting test participants

Typical problems

  • Test task creation
  • Non-disclosure agreements

Carrying out the usability test

  • Preparating the test
  • Briefing
  • Pre-test interview
  • Test moderation
  • Post-test interview
  • De-briefing
  • Typical problems

Preparation of the test results and communication

  • Psychological aspects in conveying test results
  • 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, smartphones, tablets

Practical exercises:

  • Preparing a usability test with real users
  • Creating the test plan
  • Creating the test script
  • Formulating test tasks
  • Moderation of usability tests
  • Conducting pre- / post-session interview

 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).