Beschreibung
In this hands-on training you will learn how to implement user experience (UX) and usability for medical software.
It starts with the topic of user research to understand who the users of the software are and in which environment the software is used. If the user has to pick up the phone again and again, although this would only be necessary at the end, then the context has not been properly understood. This can be done with systematic UX and usability methods.
Then usage requirements are defined and, for medical devices, usage errors are given to risk management for evaluation via the interface.
This is followed by translation into a design solution, including risk control measures. Since human behavior cannot be predicted well, the design solutions are subsequently evaluated. This can also be done by experts, but tests with users, called usability tests, are the decisive factor.
For medical software and apps, IEC 62366-1 must be met in Europe. In the USA, an FDA guidance document entitled „Applying Human Factors and Usability Engineering to Medical Devices“ applies. Here, usability testing is required at the end of development. The relevant telemetry data from the software can be used for market monitoring.
These activities require a good understanding of UX and Usability Engineering which we will provide in this seminar.
SEMINAR CONTENT
- Legal basis according to MDR and IVDR
- Norms and standards esp. IEC 62366-1:2015+AMD1:2020
- Integration of usability engineering into risk management
- Integration of usability engineering into development
- User Research as the basis of the Use Specification according to IEC 62366-1
- Use Scenarios, Critical Tasks and Analysis of Use Errors
- User Interface Specification and pragmatic creation of requirements for the user interface
- Formative evaluation to improve prototypes
- Summative Evaluation for validation of risk control measures
- Usability Engineering File and Human Factors Engineering Report
PARTICIPANTS
This basic course is also suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the topic of usability for medical device software.
This basic course is part of our online course: Medical Software Specialist!
COSTS
- Early bird (until 4 weeks before seminar): Euro 490,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 540,- (excl. VAT)
- All seminar discounts at a glance
- incl. seminar documents as PDF and a certificate of participation.
YOUR TRAINER
Dipl. Inf. (FH) Michael Engler, Managing Director of Benkana Interfaces GmbH & Co. KG
LOCATION: ONLINE
You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser. You will receive the seminar documents and the link to the virtual seminar room by email in due time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.
