Learning Objectives

After the course you should have gained:

• An overview of current rules for usability for medical devices in EU and US
• Kowledge of the standards EC/EN 62366, 62366-1/62366-2 and 606061-1-6
• How to apply requirements practically

Course outline

• Background to the area of usability
• Standard EC/EN 62366, 62366-1/62366-2 and 606061-1-6 and an overview of the close link to risk management, EU legislation and development process
• FDA Usability guidance
• Practical examples and exercises