Seminar "Usability, Requirements & IEC 62366 (2 days)"

"Want to collect requirements quickly and systematically and create a lean, IEC-62366-compliant usability file?"

How do you find out what requirements your customers and users have of a medical device? Should you just ask? Do a workshop? No! Henry Ford had the right answer: "If I had asked my customers what they wanted, they would have said a faster horse."

The making of requirements is not a matter of direct inquiry, chance or personal skill. You will learn the following in this seminar:    

• The process for collecting usage and system requirements   
• Specification of user interfaces (user interfaces)   
• The procedure for verification and validation of usability
• The development process compliant with IEC 62366-1 and IEC 60601-1-6 and the interaction with ISO 14971
• Legally compliant usability file ("Usability File")

Here you will find further information on the next dates and costs.

Didactic concept

During the seminar you will learn the subject matter permanently, practically and comprehensibly through the speaker’s lectures, through the discussions as well as case studies and exercise examples.

Day 1: Usability from the user's point of view

• Introduction - what is usability really?
• The context of use as a source for user requirements
• Derive user requirements from requirements
• Exercise: Systematically specifying user requirements

Day 2: Usability from a security and auditor's point of view

• Create usage scenarios and specify operating functions (intended use and hazard-related)
• Requirements of IEC 62366-1 and the FDA
• Use-related risk analysis
• Formative and summative evaluation
• Templates for the usability file

The seminar "Usability, Requirements & IEC 62366" is aimed at all people who are involved in the standard-compliant development of interactive medical products, especially those of medical devices and standalone software. This includes but is not limited to:

• Product managers
• Usability and requirements engineers
• (Software) developers
• Those responsible for regulatory affairs and quality management

The principles of usability and requirements engineering can be applied to any interactive system. However, the examples used in the seminar focus on standalone software and active medical devices.

Do you have questions or suggestions? Would you like to offer seminar as an in-house seminar at your organization? This gives you the option of having the content adapted specifically to your needs. Please contact us directly. We look forward to hearing from you!