You could not attend the MedTec Summit this year and missed the lecture “Efficient and safe – IVD-R compliant through Usability Engineering”? Our Lead User Experience Researcher Medical Dr. Jonas Walter has recorded this exact lecture for you. The lecture itself is held in German, but we included English subtitles for you.
In half an hour run-time, you will get clear answers to the following questions:
What are the Usability requirements imposed by the IVDR on IVD manufacturers?
How can you comply with these requirements through Usability Engineering in compliance with the regulation?
What are clear actions you need to take?
We hope you enjoy the lecture and that you can gain some insights for yourself.
Lecture by Dr. Jonas Walter (Lead User Researcher Medical) „Effizient und sicher: IVD-R konform durch Usability Engineering (German version with English subtitles):
You want to learn more about the relationship between Usability Engineering and the IVDR?
If you want to know the exact passages where the IVDR requires Usability Engineering from you, you can find them in our article “IVDR and Usability – do they belong together?“
Are you unsure what exactly has changed as a result of the transition from the IVDD to the IVDR? Then our article “What will change with the transition from IVDD to IVDR?” provides clear answers.
The article “How to prepare your Usability Testing for IVDs” provides you with a clear overview of all the undertakings you should complete before Usability Testing in order to proceed as efficiently and pragmatically as possible.
You want to know how we help manufacturers to implement Usability Engineering in compliance with the IVDR?
Under the following link we would like to give you an overview of how we do Usability Testing. We accompany you during the formative testing as well as during the final summative Usability Testing.
Conclusion
To comply with the IVDR regulations, you need to do Usability Engineering. You now know the reasons for this. How exactly the implementation can be done in your specific case, you can find out in a free get-to-know conversation with us.
What is your specific case? How does the IVDR affect your product? Let us know in the comments or get in touch via our contact form. We look forward to hearing from you!
