UX Professional Medical Devices CPUX IEC 62366 UA3040

Usability & UX training according to the UXQB® CPUX-F Curicullum adapted to development of medical devices. Usability engineering for medical devces according IEC 62366 including FDA perspective. Learn how to develop a Usability File structure. Virtual collaboration with V-Classroom-XL. The live online course for medical device profesisonals who want to take on new responsbilities in the development of medical devices.

Course code:  UA3040 DE

Why this course? Module contents

  • UX Professional CPUX Medical File with 2 certificates
  • 6 CPUX-F modules Preparation for UXQB® certification
  • Develop medical devices according to IEC 62336-1 / -2 and FDA, incl. usability file
  • IEC 62366-1 /-2 and the connection with ISO 9241 are explained in detail
  • Globally recognised "UXQB® Certified Professional for Usability and User Experience - Foundation Level (CPUX-F)" certificate
  • Usability engineering process for medical devices & human-centred design

TARGET AUDIENCE

  • Entwickler, Produktmanager, Business Analysts, Productowner, Teamleads, Projektleiter, Regulatory, Usability File Verantwortliche

PRICE

Price: 1.495,-€

20% discount Early Bird 1.195,- until 6 weeks before course start

+ 300 CPUX-F plus VAT

  • Intensivstation

    Monitoring der Vitaldaten

  • Vitaldaten

    Usability & UX Professional CPUX-F Medizinprodukte

  • Intensivstation mit Medizinprodukten

    Usability & UX Professional CPUX-F Medizinprodukte

  • Mobiles Monitoring

    Dates & course format

    • 6 half days part-time or 3 days full-time or 6 x evening intensive modules, LIVE ONLINE V-Classroom-XL or long-term format
    • 10 participants maximum - plenty of time for individual questions

    What you´ll learn in the UX Professional CPUX Medical File IEC 62366 

    UX Professional CPUX Medical File IEC 62366 + in 6 modules incl. basic certification CPUX-F according to UXQB® all basics for the development and design of medical devices according to EN62366 / IEC 62336-1 / -2 and FDA, incl. usability file.
    IEC 62366-1 /-2: The seminar teaches all important concepts for the development and design of medical devices in accordance with EN62366 / IEC 62336, from the basics of ISO 9241, context of use analysis, persona, conception, prototyping to usability testing + test + certificate.

    Globally recognised certifications:

    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 from the specialist field of usability and user experience in the most important areas of expertise.

    Usability file according to IEC 62366 & FDA preparations:

    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.

    A certification that takes you further

    Usability & UX course including preparation for the basic CPUX-F certification of the UXQB®. 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 expertise.

    Who is the seminar aimed at?

    The UX Professional medical devices seminar is aimed at anyone who is pursuing a career in the design, development, operation and/or sales of digital products. As a UX Professional, you are responsible for the design and evaluation of medical devices. You will work in the areas of user research, plan and carry out usability tests and develop interaction concepts based on the findings in order to develop and improve digital products and user experiences.

     

     

     

     

     

     

    Course modules - UX Professional CPUX Medical File IEC 62366

    • CPUX-F Foundation Level

      M01. Basics of Usability & UX - CPUX-F HCD & reference to IEC 62366

      01 Human centred design process according to ISO 9241-210:2010

      • Understanding the essential elements of human-centred design
      • 6 principles of human-centred design
      • Involving users
      • Iteration based on frequent usability evaluation
      • Addressing the entire user experience
      • Understanding the activities of human-centred design and their interrelationships
      • Understanding the purpose of the outcomes of each human-centred design activity
      • Understand the similarities and differences between IEC 62366-1 / -2 & ISO 9241-210
      • Human-centred quality

      08 Human-centred design maturity

      • Maturity model & determine maturity level
      • Measures to improve the maturity level
      • Other maturity models, UX maturity, UX Maturity & UX Strategy


      02 Usability & user experience according to ISO 9241-11:2018

      • Usability & user experience
      • Difference between usability and user experience
      • Effectiveness, efficiency, satisfaction
      • Usability metrics of ISO 9241-11:2018 as acceptance criteria for medical devices
      • Interactive system, user-system interaction, user interface and user interface element
      • Accessibility & assistive technologies
      • Prevention of harm through use


      03. planning activities for human-centred design in a project

      • Human-centred quality objectives

      Practical exercises:

      • Simple examples of user interfaces that illustrate the essential characteristics of usability
      • Introduction of the CPUX-F certificationIntroduction

       

      M02. CPUX-F - with reference to IEC 62366 - Understanding and defining the context of use - Usability Evaluation & Testing

      04 Analysing and defining the context of use

      Elements of the context of use

      • Goals, tasks, resources, environment
      • Persona, users and user groups
      • Primary users, secondary users, indirect users
      • Actual scenarios versus usage scenarios (target scenarios)
      • Interview and observation techniques
      • Focus group
      • User journey map

      Practical exercises:

      • Brainstorming - participants think about users, tasks, resources and environment and write them on post-it notes

      07. evaluation of design solutions

      • Usability evaluation
      • Differentiate between usability test, usability inspection and user survey
      • Usability test
      • Main activities of the usability test
      • Preparing, conducting, analysing and reporting usability tests
      • Usability test guide - test script
      • Formulate usability test tasks
      • Documenting and communicating usability test results

      Practical exercises:

      • Familiarisation with a tool for unmoderated / crowd usability tests with video recording (e.g. Rapidusertests)
      • Formulating test tasks for a usability test with video recording
      M03. CPUX-F - with reference to IEC 62366 - User Needs & User Requirements

      Usability inspection & user survey

      • Inspections and user surveys
      • Types of inspection
      • Inspection criteria
      • User survey

      05 Determining the user requirements

      • Requirement / User Need
      • Requirement / market requirement / organisational requirement
      • User requirement vs. stakeholder requirements
      • Qualitative / quantitative user requirements
      • Acceptance criteria

      Practical exercises:

      • Identifying user needs - What does the user really need?

      06. design solutions

      • Iterative design process
      • Usage scenarios and storyboards
      • Task modelling as the basis for task-appropriate interactions
      • Interaction specification, user system interaction
      • Low & high fidelity prototyping
      • Information architecture and navigation structure
      • Workflows & wireframes
      • User guidance
      • Ethical & sustainable design
      • Interaction principles ISO 9241-110:2020
      • Design patterns, user interface elements
      • Basic principles of 'Good UX Design',
      • Golden ratio, aesthetics
      • Psychology of perception - mental models,affordances
      • Design principles
      • Design and design rules
      • Material Design Styleguide - IOS Styleguide

      Practical exercises:

      • Formulating usage scenarios using the example of a mobile app / tablet app

      Usability inspection & user survey

      • Inspections and user surveys
      • Types of inspection
      • Inspection criteria
      • User survey

      05 Determining the user requirements

      • Requirement / User Need
      • Requirement / market requirement / organisational requirement
      • User requirement vs. stakeholder requirements
      • Qualitative / quantitative user requirements
      • Acceptance criteria

      Practical exercises:

      • Identifying user needs - What does the user really need?

      06. design solutions

      • Iterative design process
      • Usage scenarios and storyboards
      • Task modelling as the basis for task-appropriate interactions
      • Interaction specification, user system interaction
      • Low & high fidelity prototyping
      • Information architecture and navigation structure
      • Workflows & wireframes
      • User guidance
      • Ethical & sustainable design
      • Interaction principles ISO 9241-110:2020
      • Design patterns, user interface elements
      • Basic principles of 'Good UX Design',
      • Golden ratio, aesthetics
      • Psychology of perception - mental models,affordances
      • Design principles
      • Design and design rules
      • Material Design Styleguide - IOS Styleguide

      Practical exercises:

      • Formulating usage scenarios using the example of a mobile app / tablet app 

       

      M04. CPUX-F - with reference to IEC 62366 - Design Solutions & Exam Preparation

      06 Design Solutions

      • Iterative design process
      • Usage scenarios and storyboards
      • Task modelling as the basis for task-appropriate interactions
      • Interaction specification, user system interaction
      • Low & high fidelity prototyping
      • Information architecture and navigation structure
      • Workflows & wireframes
      • User guidance
      • Ethical & sustainable design
      • Interaction principles ISO 9241-110:2020
      • Design patterns, user interface elements
      • Basic principles of 'Good UX Design',
      • Golden ratio, aesthetics
      • Psychology of perception - mental models,affordances
      • Design principles
      • Design and design rules
      • Material Design Styleguide - IOS Styleguide

      Practical exercises:

      • Formulating usage scenarios using the example of a mobile app / tablet app
      • Exam preparation CPUX-F

       

      M05. Usability Engineering I & Usability File - IEC 62366-1 / -2 REVISED

      The usability file according to IEC 62366

      • Structuring the serviceability file
      • Specifying usability requirements
      • Procedures for formative and summative evaluation of usability
      • Former designations Verification and validation of suitability for use
      • Creation of test plans and performance and documentation of tests
      • Categorise content; in which file (usability file, risk management file, quality management manual, etc.)
      • Which results should be documented and how the files are linked

       

      M06. Usability Engineering II & Usability File - IEC 62366-1 / -2 REVISED

      Differences in IEC 62366 / FDA conformity / Interaction with ISO 14971

      • IEC 62366 and the human centered design process
      • Interaction of IEC 62366 and risk management according to ISO 14971
      • Structure of a usability file, documentation structure
      • Usability testing processes: including inspection process (e.g. tests against style and design guidelines, ISO 9241, heuristics),
      • Selection of appropriate evaluation method - participant observation (usability testing) as well as quantitative and qualitative user surveys
      • Documentation of test specification and test results
      • FDA conformity aspects

       

      Analysing and defining the context of use

      • Planning and carrying out context of use analyses
      • Collect and document context of use information
      • Plan, prepare and conduct interviews, observations and focus groups

      Practical exercises:

      • Interviews
      • Develop and describe a persona
      • Analyse and document task models


      Determine user requirements

      • Identify requirements in context of use information
      • Derive and structure user requirements from requirements
      • Consolidate user requirements
      • Work products and roles
      • Design thinking & human-centred design


      Practical exercises:

      • Deriving requirements from context of use information

       

      P07. Certificate exams - CPUX-F + UX Professional Medical Devices

      Examination "Certified Usability & UX Professional Foundation Level" (Optional: please indicate when registering whether you wish to register for the CPUX-F examination)

      • Participants take the Certified Professional for Usability and User Experience Foundation Level exam.
      • The exam contains 40 multiple-choice questions.


      Exam and certificate "Usability Academy - UX Professional Medical Devices"

      • Examination to become a Usability & UX Expert
      • Online test with approx. 40 questions
      • Multiple choice questions
      • Award of the Usability Academy certificate

      Facts & Figures - UX Professional CPUX Medical File IEC 62366

      • Description

        • UX training according to the curriculum of the International Usability and User Experience Board (UXQB) incl. exercises
        • Preparation for the "UXQB® CPUX-F" certification 
        • LIVE ONLINE seminar with V-Classroom-XL - Video Audio - ONLINE REALTIME WHITEBOARD - eLearning Portal - Virtual Classroom
        • 12 modules of 4 hours each (full day, morning, afternoon) ONLINE V-Classroom-XL Seminar - Training & Workshop + Test + Certificate
        • 12 half days, or 12 x evenings, or weekend 24h Flex seminars
        • 48 hours full of UX methods and concepts
        • 10 participants maximum - NO mass event - plenty of time for individual questions

        Format:

        • 12 half days in the mornings or afternoons with fixed dates
        • 5 full days full-time


        Funding:

        • A similar course is funded up to 100% by the German Arbeitsagentur with Bildungsgutschein registration no.: 31M1220078

         

      • Certificates

        Exam "Certified Usability & UX Professional Foundation Level"

        • Participants take the Certified Professional for Usability and User Experience Foundation Level exam
        • The exam contains 40 multiple-choice questions.
        • Exam and certificate "Usability Academy - Usability & UX Expert"

        Exam "Usability & UX Expert Medical Devices"

        • Online test with approx. 40 questions
        • Multiple choice questions
        • Award of the Usability Academy certificate
      • Audience

        • Developers, product managers, product owner, medical devices
        • Quality managers, software engineers for medical devices
      • Coursefees

        Online course: € 1,495 plus VAT.

        Early bird price: € 1,195 (up to 6 weeks before the start of the course) plus VAT.

        Exam fee CPUX-F: 300,- Euro plus VAT

        Recommended prerequisite: None

        If you would like to redeem an education voucher, please let us know. We will check the requirements together. We will then take care of everything else for you.

        Here you will find all the information on how to obtain an education voucher and what is subsidised.


      • Context of use

        Medical device context of use

      • KJ Workshop

      • Persona

      • User Journey map

      Events - UX Professional CPUX Medical File IEC 62366

      Afternoon

      Event Event Date - Event End Date Individual Price Register

      UX Professional CPUX Medical File IEC 62366 ENGLISH in the afternoon UA3040

      UX Professional CPUX Medical File IEC 62366 – a 6 modules course - 6 mornings or 6 afternoo...

      16.12.2024 - 23.12.2024 14:00 - 18:00

      1,495.00€

      FAQ - Frequently asked questions

      General Terms and Conditions

      General Terms and Conditions for ONLINE events of GoDigitalXL UG and face-to-face events of aventaurus Consulting GmbH. The name "Usability Academy" is a brand name used by both companies in the respective business area training.

      For ease of reading only, the gender-differentiated spelling is omitted in the following.
      1. division of business

      1.1 GoDigitalXL UG is responsible for all ONLINE seminars as of 03.01.2020.

      ONLINE Seminars:

      GoDigitalXL UG
      Usability Academy
      Bahnhofstr. 1
      67655 Kaiserslautern

      Phone: +49 631 3160 5793
      Fax: +49 631 3160 5794
      E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.

      1.2 As of 03.01.2020, Aventaurus Consulting GmbH is responsible for the implementation of all face-to-face seminars.

      Classroom seminars:

      aventaurus Consulting GmbH
      Usability Academy
      Bahnhofstr. 1
      67655 Kaiserslautern

      Phone: +49 631 3160 5793
      Fax: +49 631 3160 5794
      E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.
      2. scope of application

      These General Terms and Conditions apply to all contracts concluded with the Usability Academy, a business division of GoDigitalXL UG and aventaurus Consulting GmbH Kaiserslautern, for participation in seminars and workshops from the Usability Academy's range.
      3 Conclusion of contract

      Registration for participation in seminars, training courses or other events of the Usability Academy (hereinafter: seminars) must be made in writing using the Usability Academy registration form (by letter, e-mail or fax) or online and must be received in full by the Usability Academy within the deadline specified in the event documents, if applicable. Due to the limited number of participants, registration does not constitute a binding contract. If the Usability Academy offers an information event, the contract will only be concluded after the information event by both parties signing a registration confirmation or a contract.
      4 Scope of services and prerequisites for participation

      4.1 The scope of the Usability Academy's services (location, time, duration, course topic, instructors, educational goal, price, etc.) results from the description of the Usability Academy programme and the training brochures, which were announced at the time of registration, displayed in the business premises and published on the Internet.
      4.2 The Usability Academy can make participation in an event dependent on personal and/or material prerequisites. As far as possible, information about the necessary prerequisites is provided in the Usability Academy programme and on the Internet.
      4.3 The learning material will be activated on the eLearning Portal 10 days before the start of the course. If an earlier activation is desired, the possibility of withdrawal ends with the activation.

      4.4 The following applies to CPUX-F certification: After receipt of the access data for the eLearning portal to the CPUX-F documents, a minimum fee of 250 euros is due, even if the course is cancelled at a later date. For the other courses: 20% of the course fee.
      5. fee

      5.1 The participant must pay the contractually agreed fee in accordance with the invoice issued by the Usability Academy. The participant is liable for payment of the fee even if the fee, or parts thereof, are to be paid by a third party (e.g. company, employer, professional development service). The statutory value added tax shall apply. In the event of non-payment of the fee, the participant may be excluded from further participation in the course.
      5.2 No discount can be granted for courses that have already been discounted.
      6. course location

      The courses take place at the Usability Academy, or at a location named in the registration confirmation.
      7. right of withdrawal, non-participation and cancellation

      7.1 The applicant has a right of withdrawal in accordance with the following conditions:
      A withdrawal or cancellation must always be declared in writing (by e-mail, fax or post). Depending on the time of withdrawal, the organiser will charge a fee. The applicant is entitled to prove that no damage or a reduction in value has occurred at all or that the damage or reduction in value is considerably less than the fee charged.

      In the event of withdrawal/cancellation, the following amount will be charged or retained:
      ⇒ from the date of registration to 29 days before the start of the event : 250 € processing fee.
      ⇒ 28 to 15 days before the start of the event: 25% of the participation fee
      ⇒ 14 - 8 days before the start of the event: 50% of the participation fee
      ⇒ 7 days or more before the start of the event: 100% of the participation fee.

      No cancellation fee will be charged if a substitute person is named. This change of registration must also be made in writing and must be made by the original registrant. The original registrant remains obliged to pay the participation fee to the organiser until the change has been made.

      7.2 The Usability Academy can terminate the contract without notice for good cause in accordance with § 626 BGB. Important reasons are, in particular, the disruption of the processes of the further training events and the non-observance of the house rules despite a request to refrain from the disruption or violation. Partial amounts already due shall not be refunded.
      7.3 Cancellation and withdrawal must be made in writing. The relevant time for termination and withdrawal is the time of receipt of the declaration by the recipient of the declaration.

      7.4 In the event of mere full or partial non-participation, the participant remains obliged to pay the full participation fees. This applies irrespective of whether the default is the fault of the participant or not.
      7.5 In the event of a withdrawal, no PayPal fees will be refunded for PayPal payments.

      8. change and cancellation of events

      The Usability Academy reserves the right to cancel or change an event under the following conditions up to 7 calendar days before the start:
      8.1 A cancellation or postponement can only be made if there is a creditable interest on the part of the Usability Academy. This is particularly the case if the minimum number of participants is not reached or if the event cannot be held due to force majeure, impossibility or the speaker's absence.
      8.2 The participant will be notified of this under the contact details stated in his/her registration. In the event of cancellation, any participation fee already paid will be refunded. The same applies in the event that the participant is unable to attend the new alternative date of the respective event. Further claims on the part of the participant are excluded.
      8.3 The Usability Academy reserves the right to replace speakers, to name additional speakers and to change the course of the event, provided that this does not change essential features of the event and the change is reasonable for the participant. The participant cannot derive any claims from this, e.g. for withdrawal from the contract or reduction of the fee.
      9 Liability

      The Usability Academy is liable for the obligations arising from the contract with the due care of a prudent businessman. Claims by the participant for damages are excluded. Excluded from this are damages arising from injury to life, body or health if the Usability Academy is responsible for the breach of duty, other damages based on an intentional or grossly negligent breach of duty by the Usability Academy and damages based on an intentional or negligent breach of duties typical of the contract by the Usability Academy. A breach of duty by the Usability Academy is equivalent to a breach of duty by a legal representative or vicarious agent.
      10 Data Protection and Copyright

      10.1 Personal data of the participant will be processed by the Usability Academy exclusively for the purpose of handling the event. It will not be passed on to third parties.
      10.2 The participant receives ownership of the copyrighted course documents issued for the respective event and undertakes not to pass these on to third parties or make them accessible to third parties.

      11. cancellation policy for consumers

      If you are a consumer and have transmitted this registration to us by means of a means of distance communication (e.g. by letter, fax or e-mail), you have a right of withdrawal. In this case, please note the following cancellation policy:

      Right of withdrawal

      You may revoke your contractual declaration in writing (e.g. letter, fax, e-mail) within 14 days without stating reasons. The time limit begins after receipt of these instructions in text form, but not before you have also been provided with a contract document, your written application or a copy of the contract document or the application and also not before we have fulfilled our information obligations pursuant to Article 246 § 2 in conjunction with § 1 paragraph 1 and 2 EGBGB (Introductory Act to the German Civil Code) as well as our obligations pursuant to § 312g paragraph 1 sentence 1 BGB (German Civil Code) in conjunction with Article 246 § 3 EGBGB. The timely dispatch of the revocation is sufficient to comply with the revocation period. The revocation is to be sent to:

      ONLINE Seminars:

      GoDigitalXL UG
      Usability Academy
      Bahnhofstr. 1
      67655 Kaiserslautern

      Presence seminars:

      aventaurus Consulting GmbH
      Usability Academy
      Bahnhofstr. 1
      67655 Kaiserslautern

      Phone: +49 631 3160 5793
      Fax: +49 631 3160 5794
      E-mail This email address is being protected from spambots. You need JavaScript enabled to view it.
      12. consequences of revocation

      In the event of an effective revocation, the services received by both parties must be returned and any benefits derived (e.g. interest) must be surrendered. If you are unable to return or surrender the received goods or services or benefits (e.g. benefits of use), or are only able to do so in part or in a deteriorated condition, you must compensate us for the loss of value. This may mean that you must nevertheless fulfil the contractual payment obligations for the period until revocation. Obligations to refund payments must be fulfilled within 30 days. The period begins for you with the dispatch of your notice of revocation and for us with its receipt.
      12.1.1 Special notes Your right of revocation expires prematurely if the contract has been completely fulfilled by both parties at your express request before you have exercised your right of revocation.

      End of the cancellation policy
      13. final provisions

      13.1 The place of performance and jurisdiction for all obligations arising from this agreement is - as far as legally permissible - Kaiserslautern. If a contractual partner fulfils the requirement of § 38 Paragraph 2 of the German Code of Civil Procedure (ZPO) and does not have a general place of jurisdiction in Germany, the place of jurisdiction is the registered office of the Usability Academy.
      13.2 Should individual provisions of these General Terms and Conditions for Events be invalid or void, this shall not affect the validity of the remaining provisions. The parties undertake to replace the invalid provision with a provision that is as close as possible in meaning to the invalid provision and is valid.

      Where do the seminars take place?

      Currently all seminars take place LIVE ONLINE

      In-house trainings are also held: This email address is being protected from spambots. You need JavaScript enabled to view it.

      How does the online training work?

      For the online training you need:

      • a fast internet access,
      • a notebook with camera
      • a microphone.

       

      - The trainer will be available via video

      - The software we use is Zoom. The routing will be exclusively Europe, North America, India and South America. Other countries have been excluded.

      - We are using V-Classroom XL & a whiteboard software.

      - There is no installation for this.

      - For Zoom and Whiteboard you will receive an invitation by email

      - There is NO additional cost to you for the online tools

      Which payment methods are possible?

      Payment methods:

      - On account

      - PayPal

      - MasterCard

      - VISA

      - Amex

      How does the course take place?

      At the scheduled times, a trainer will meet with you via Zoom and you can then work on the content together. You should find an undisturbed place with a good internet connection.

      How many participants are in the course?

      Normally, our courses consist of about 2-10 participants. This offers both the advantage that our trainers can take enough time for the questions of the group, and that you can always exchange and learn together.

      What qualifications do the trainers of the courses bring with them?

      Our trainers are certified usability and user experience professionals. This means we have a comprehensive understanding of the content we teach you.

      How do I know when which modules are taking place?

      We have a calendar in which all modules and when they take place are stored. You will receive the appropriate Zoom invitation from us via link.

      How does it work with the CPUX-F test?

      You can book the CPUX-F exam directly when booking the course. Then we will take care of the registration.

      The date for the exam can be chosen freely, but usually we need 3-4 days in advance to be able to make the registration. It is best to use a few days after the course for intensive preparation and not to take the exam directly afterwards.

      If you have not yet decided whether you want to take the exam, you can register for the exam yourself at a later date.

      Is this a mass event if it's online?

      No. Normally, our courses consist of a maximum of 10-12 participants*. This offers both the advantage that our trainers can take enough time for the questions of the group, and that you can always exchange ideas and work together on the practical exercises.

      *For companies we can adjust the group size on request.

      Questions about the seminars Usability Engineering Medical Devices ? Let's meet with ZOOM :-)

      When would you have time for a ZOOM meeting? We have free slots every day between 13:00 and 13:30.

      Please choose a day and the topic


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