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UA3040 Usability Engineering MPG Medical Product File IEC 62336 - CPUX-F 

The training teaches all important concepts for the development and design of medical devices according to EN62366 / IEC 62336 and all basic concepts of Usability Engineering according to the worldwide recognized CPUX-F curriculum. From the basics of ISO 9241, through context of use analysis, task analysis, persona, conceptual design, prototyping up to usability testing + test + certificate.

The training for every UX Professional in medical device development who wants to implement the latest changes in IEC 62336-1 -2 and for FDA.

The training has 2 major modules: Module 1 is about the CPUX-F curriculum. Module 2 is about how to allocate the work products into the medical product file. It is including preparation for basic certification CPUX-F according to UXQB® and all basics for the development and design of medical devices according to EN62366 / IEC 62336 and FDA, incl. Usability File.

Unique: Planning, execution and evaluation of remote / not supervised usability tests with real users. The focus of the training is on practical exercises. For all concepts of the CPUX training, there are extensive practical exercises for tablet and touch design of medical devices.

Usability File: The training shows which work results should be found in the usability file. The seminar Usability Engineer Medical Products provides all professional beginners with the most important Usability & UX methods according to the official criteria of IEC 62366 and the curriculum of the UXQB (Usability & UX Qualification Board).

Worldwide recognized 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 basics of usability and user experience. 

  • ONLINE Training with V-Classroom-XL - Video Audio - ONLINE REALTIME WHITEBOARD - eLearning Portal - Virtual Classroom
  • Exam preparation training for „UXQB® CPUX-F certification  1 454x340 
  • UX Training according to International Usability and User Experience Board (UXQB) incl. exercises
  • 3 days online V-Classroom-XL training & workshop + test + certificate
  • 24 hours full of UX methods, concepts
  • 10 Participants maximum - NO mass training - much time for individual questions

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)

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 use 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

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

  • Exam preparation CPUX-F

Practical exercise:

  • Develop low-fidelity prototype

Module 5: The usability file according to IEC 62366

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 6: 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

Practical 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

Practical exercise:

  • Identify needs in the context of use


Test and Certificate "Usability Academy - Usability Engineer Medical Products"

  • Exam as a Usability Engineer Medical Products
  • Online test with about 40 questions
  • Multiple choice questions
  • Usability Academy Certificate

Included in the price:

  • Access to the eLearning portal at registration
  • Exam preparation questions CPUX-F on the eLearning portal
  • Several experiments with mixing of the answers in the portal
  • Glossary CPUX-F in the portal
  • Documentation available for download in PDF format

*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 


1.395,- Euro plus VAT without examination 

1.295,- Euro plus VAT with early bird discount (up to 6 weeks before the course starts)

300,- Euro CPUX-F certification exam plus VAT

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


Further Courses: UA3100 Usability & UX Expert Medical Products

Recommended prerequisite: None - Also suitable for beginners





Dates UA3040 Usability Engineer Medical Products CPUX-F