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. 

Module 1:

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 exercise:

  • The difference between Usability & User Experience, practical examples

Understanding and specifying the usage context:

  • User Groups, User Group Profiles and Personas
  • Primary Users, Secondary Users, Indirect Users
  • Current scenarios versus target scenarios
  • Interview and observation techniques

Practical exercise:

  • Make reference to the Usability File

Specifying the user requirements

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

Practical exercise:

  • Identifiying user needs - What does the user really need?
  • Derivation of usage requirements
  • Make reference to the usability file

Specify the interaction

  • Task modeling as a basis for task-appropriate interaction
  • Interaction specification with usage scenarios and storyboards
  • Usage objects, information architecture and navigation
  • Basic Principles of 'Good UX Design', Golden Rules
  • Perception Psychology - Mental Models, Affordances, Design Priciples
  • Design and design rules

Practical exercise:

  • Formulating usage scenarios
  • Developing storyboards and workflows
  • Harmonization of the Association via Wireframes
  • Iterative User Centered Design & SCRUM
  • Developing detailed use cases
  • Development of interactive prototypes and their documentation in the usability file
  • Exercise with Axure

Usability testing

  • Types of usability tests
  • Select and formulate usability test tasks
  • Prepare and run usability tests
  • Document and communicate usability test results
  • Inspections and user surveys
  • Types of inspection
  • 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
  • Formulation of the screening criteria for usability tests
  • Preparation of documents for a remote / crowd usability test
  • Evaluation of test videos of the probands

Process management and use of methods

  • Process roles
  • Work results in usability engineering

Module 2:

Usability File (IEC 62366)

  • Structure of the usability file
  • Specify requirements for usability
  • Verification and validation method for usability
  • Preparation of test plans, execution and documentation of tests
  • Arranging content; in which file (usability file, risk management file, quality management manual, etc.)  should results be documented and how should the files be 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
  • Construction of a usability file, documentation structure
  • Procedure for testing usability: U.a. Inspection procedures (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 compliance issues

The training is based on the curriculum of the International Usability and User Experience Board (UXQB) and concludes with the UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F) certificate exam. Interested participants can optionally take the Certified Professional for Usability and User Experience exam on the 3rd day from 3:30 to 4:45 pm.

The training content corresponds to the curriculum and glossary of the International Usability and User Experience Qualification Board (UXQB), which is accepted by the German Association of Usability Professionals (German UPA).

 

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

CPUX-F certification exam:

300,- plus VAT

 

Price: 1.395,- €  or   1.655,- $* plus VAT 

 

Early bird prices*  :  1.115,- € or 1.320,- $ plus VAT

*registration until 6 weeks before start of training

* exchange rates may variate, price basis is Euro

Online seminar dates: ...here

 

Recommended prerequisite: None - Also suitable for beginners

Further Courses: UA3100 Usability & UX Expert Medical Products

Questions?