Outcome
The participants will achieve an understanding of how to document the usability of medical devices in order to achieve compliance through an introduction to the usability engineering process, a thorough walk-through of the requirements in IEC 62366-1 and -2 and the FDA Human Factor Engineering guide, and practical application of usability techniques during design and post marketing.
 
Content
Usability of medical devices and the documentation of the usability engineering process have become increasingly important for the medical device industry. 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, handling of risk related to the user interface and the summative evaluation of the user interface design. Preparation of the usability engineering file will be described and different methods for integrating the file in development documentation will be suggested.
 
Who should attend
This course is targeted at (but not limited to):

• Usability Engineers
• Product design engineers
• Risk managers
• Regulatory managers
• Project managers
• Quality managers

Trainers
Peter Bøge, Design Control Specialist, Novo Nordisk A/S
Marianne Witt, Senior Human Factor Specialist, Ferring Pharmaceuticals

"Liked everything"

"The presenter's subject knowledge was very good, and also the way things was presented. I also found the balance/relation between Usability and Risk Management interesting and useful"

"I liked the link between theory and practical examples and exercises"

"Instructors supplemented each other well: Good mix of regulatory and hand-on experience. Good and safe and down-to earth - felt ok to ask all kind of questions"

"Really good and a lot of (for me) new stuff"

"It was good to do the team work and get the interaction"

"Very operational approach with examples and cases"

Participants, Spring 2023