Usability engineering in Medical Devices

About the course

Learn about the essential requirements for ensuring medical devices meet usability standards in Europe and the United States.

This course explores the requirements, providing you with a better understanding of how to comply with the regulations and successfully enter the market. The course is given in English.

Who Should Attend?

This one-day course is aimed at those in the field of medical devices who needs knowledge about how the requirements affect your product and product development.

No matter what stage of development you are in, this course will help you plan and include usability in your development process and be compliant with the necessary requirements. During the course day you will get an overview of standard/guidance as well as understanding how to apply them practically.

Recommended prior knowledge: Participants should have a basic knowledge of medical device development and medical device legislation. The course will be held in English unless only swedish speaking participants.

Learning Objectives

After the course you should have gained:

• An overview of current rules for usability for medical devices in EU and US
• Detailed knowledge of the standards IEC/EN 62366-1 and IEC/EN 60601-1-6
• How to apply requirements practically

Course outline

• Background to the area of usability
• Standard EN 62366-1 in detail and the connection to the regulations and background of EN 62366 and EN 60601-1-6
• Overview of FDA´s “Applying Human Factors and Usability Engineering to Medical Devices”
• Overview of the close link to risk management
• “FDA´s Applying Human Factors and Usability Engineering to Medical Devices” and 62366-1, what is the difference?
• Practical examples and exercises