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

"Great communicators with different backgrounds that give a broad perspective on usability"

"Very competent course leaders with extensive experience from writing standards and performing studies"

"Good mix of theory and exercises. Lot of knowledge within the field. Hands on products to use etc."

"It was a nice general introduction to usability engineering"

"Good combination between teaching and excises. Also the teachers were a good split between Risk approach / Usability"

"I liked the exercises because they give an idea of what happens in the "real life""

"Liked the way it was build with information, followed by exercises to better get a feeling of how to do in practice"

Participants, Spring 2024