Seminar "Usability, Require­ments, and IEC 62366-1"

The seminar covers the following topics: 

• Contents of IEC 62366-1:2015 including Amendment 1/2020 
• Contents of the FDA guidance document “Applying Human Factors and Usability Engineering to Medical Devices” 
• Systematic derivation of user requirements from user needs in the context of use 
• Structuring of user requirements according to core and sub-tasks 
• Interaction principles according to ISO 9241-110 
• Survey and presentation of user groups and use environment 
• Use-related risk analysis 
• Specification of use scenarios for normal use (correct use without user errors and use with user errors/hazard-related use scenarios) 
• Systematic derivation and specification of primary operating functions and characteristics with regard to safety and possible use errors 
• Development-accompanying testing of usability (formative evaluation) 
• Post-development testing of usability (summative evaluation) 
• Standard-compliant documentation of the usability file

After the seminar, you will: 

• know the procedure for identifying requirements (user needs). 
• be able to derive user requirements from needs. 
• be able to systematically specify and structure user requirements. 
• be able to create use scenarios and specify operating functions. 
• be familiar with the regulatory background (IEC 62366-1 and FDA). 
• be familiar with the procedures for formative and summative evaluation. 
• be familiar with the standard-compliant documentation of the usability file (including templates).

This seminar is designed for: 

• Product Managers who want to design their medical devices optimally for users and provide notified bodies and the FDA with reliable evidence of the safety of the devices for users and patients. 
• Usability Engineers who want to create audit-proof usability files. 
• Development staff who wish to understand how to design medical devices safely and document this.

Participants can easily follow this seminar, even without any special prior knowledge. Understanding your own medical devices is helpful.

After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.  

An invoice will be sent to you within the next 48 hours, with a payment term of 14 days. If this payment term is not feasible for your company, please send a short e-mail to [email protected] to find a solution.  

Three days before our online seminars and workshops, you will receive two e-mails: The first contains the final link to the seminar and the second contains the access data to a cloud folder in which you will find documents for preparation, exercises, and presentations.   

If the seminar or workshop takes place in person, you will also receive the access link to your seminar documents three days before the date of the event. We will also provide documents in digital form for in-person events.

The seminar takes place either in person or online.  

Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We recommend dialing in 20 minutes before the seminar begins so that any technical problems can be resolved in good time. If you have any questions or encounter any issues, our team is always available to help. 

We also recommend that you arrive at the seminar room approximately 20 minutes before the start of the face-to-face events.

At the end of the seminar, you will receive a feedback link for evaluation. The following day, we will send you your certificate of attendance.

If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The documents provided also include an emergency number to help you in urgent cases. 

Our general FAQ section answers further technical and organizational questions.