In this practical seminar, you will learn how to efficiently perform formative and summative usability evaluations while meeting the regulatory requirements of IEC 62366-1 and the FDA.
Using an example device, you will apply the essential parts of the usability engineering process to plan and perform a summative usability evaluation and carry it out yourself.
Do you have any further questions? Would you like another appointment or consider an In-house seminar? Get in touch with us!
We will first introduce you to the similarities and differences between formative and summative evaluations in the context of the relevant requirements. Based on best practices, you will learn when each usability evaluation method is best used to identify the strengths and weaknesses of the user interface and unknown use errors. This will increase your chances of developing devices that are not only safe but also successful.
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You will plan a summative evaluation on your own as part of active participation in a real-life case study. We will then head to our fully equipped usability lab, where you will have the opportunity to slip into the role of moderator or note-taker, conduct the study you have just planned, and then analyze and document the results in accordance with industry standards. This practical experience enables sustainable learning and allows you to directly apply the knowledge you have acquired in your company.
You will learn how the intelligent use of tools can simplify usability evaluations and significantly reduce the time required for evaluation. We show you how to easily document observed use difficulties, use errors, and other relevant observations, evaluate them systematically, and create a clear, standards-compliant report. For documentation, you receive our tried-and-tested templates, which we have used successfully in hundreds of projects.
Our experienced usability expert has successfully conducted numerous formative and summative usability evaluations for various medical and IVD medical devices worldwide. Benefit from this comprehensive practical knowledge and valuable tips and tricks to conduct successful usability evaluations yourself in the future.
There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.
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The seminar covers the following topics:
In this seminar, you will learn how to efficiently implement the usability engineering process and perform formative and summative usability evaluations while meeting the regulatory requirements of IEC 62366-1 and the FDA.
Using a practical case study, you will not only be introduced to the activities of the usability engineering process step by step but will also carry them out yourself.
You will gain the knowledge and skills to implement the usability engineering process and to plan, carry out, and analyze usability evaluations.
The seminar is aimed at anyone involved in the development of medical devices, in particular:
Participants can easily follow this seminar, even without any special prior knowledge. Understanding your own medical devices is helpful.
To participate optimally in the seminar, participants need a laptop and the latest versions of the IEC 62366-1 and IEC 62366-2 standards.
Please get in touch with us if we can assist you in this regard or provide you with the standards.
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.
Dr. Philipp Schleer studied mechanical engineering and focused on medical technology for his master's degree. During his doctorate, he discovered his passion for human-machine interaction in the development and evaluation of assistance systems for robotic surgery regarding their usability. At the Johner Institute, he supports our customers in the planning and implementation of large-scale projects, usability evaluations, the implementation of usability processes, and standard-compliant documentation in accordance with IEC 62366.
We are also happy to offer our seminars, courses, and workshops in-house. Depending on your needs, these can be held online or at your premises.
Please feel free to contact us.
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