Medical Device Usability

The participants will achieve an understanding of ISO/IEC 62366 and the Usability Engineering Process and gain experience in the practical application of usability techniques during the design face and post marketing in order to be able to document the usability of medical devices to achieve compliance regarding medical device usability.

Outcome
The participants will achieve an understanding of ISO/IEC 62366 and the Usability Engineering Process and gain experience in the practical application of usability techniques during the design face and post marketing in order to be able to document the usability of medical devices to achieve compliance regarding medical device usability.
 
Content
Usability of medical devices and the documentation of the usability engineering process have become very hot topics to the medical device industry with the publication of ISO/IEC 62366 – Application of Usability Engineering to Medical Devices. During the course the participants will learn about the usability engineering process including specification of a medical device application with focus on user interface, identification of hazardous situations related to usability, preparation of testable usability requirements, verification and validation of the user interface design. Preparation of the usability engineering file will be described and different methods for implementation of the file in existing development documentation will be suggested.
 
Who should attend
This course is targeted at (but not limited to):
-         - Product design engineers
-        -  Risk managers
-         - Regulatory managers
-         - Project managers
-         - Quality managers
 
Instructor

Hanne Andersen, Senior Consultant, AlfaNordic

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Kontakt

Morten Petersen
Kursuskoordinator
49184703