Description
For medical software and apps, IEC 62366-1 must be fulfilled in Europe. In the USA, an FDA guidance document entitled „Applying Human Factors and Usability Engineering to Medical Devices“ applies. Before release many cases require summative evaluations including usability testing at the end of development.
These activities require a good understanding of UX and usability engineering which we will provide you with in this seminar. In this hands-on training, you will learn how to implement user experience (UX) and usability for medical software.
Starting with user research, in order to understand who the users of the software are and in which use environment the software is used. E.g. if a user has to pick up the phone again and again, even though 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 use errors are identifed and passed on to risk management for evaluation.
This is followed by the translation into a design solution including risk control measure. Since human behavior is not easily predictable, the design solutions are evaluated. This can also be done by experts, but tests with users, called usability tests, are the standard method.
SEMINAR CONTENT
- Legal requirements according to MDR and IVDR
- Norms and standards esp. IEC 62366-1:2015+AMD1:2020
- Integrating usability engineering into risk management
- Integrating usability engineering into development
- User Research as the basis for the Use Specification according to IEC 62366-1
- Use Scenarios, Critical Tasks and Analysis of Use Errors
- User Interface Specification and pragmatic creation of user interface requirements
- Formative evaluation for the improvement of prototypes
- Summative evaluation for the validation of risk control measures
- Usability Engineering File and Human Factors Engineering Report
PARTICIPANTS
This basic course is also suitable for participants with little or no previous knowledge. This course is a great introduction for those new to the industry or starting a business.
This basic course is part of our online course: Medical Software Specialist!
YOUR TRAINER
Dipl. Inf. (FH) Michael Engler, Senior Consultant, Managing Director at EMPIANA GmbH
COSTS
- Early bird (until 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (starting 4 before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and a certificate of participation
- Overview of all discounts
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 in time by email. 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.
