Learn in just one day how to use large language models (LLMs) specifically in developing medical devices – from the initial idea to post-market surveillance.
This practical workshop with product expert Mario Klessascheck and regulatory and AI expert Prof. Dr. Christian Johner will teach you specific methods that will enable you to drastically reduce the time needed to develop and document your medical devices while remaining compliant with the law.
You will learn how to use LLMs as brainstorming partners, development engineers, and reviewers for every development document, from requirements specifications to instructions for use. You will also understand the limitations of AI, enabling you to make informed decisions about where human expertise remains indispensable and where AI can provide optimal support.
“A lot of content conveyed in a compact way. Good level, from a rough overview to specific examples. Exercises provide insight into how things could actually work.”
“Clear examples and lots of useful knowledge. Presented by people who absolutely understand what they are doing.”
In hands-on exercises, you will use your familiar terminology to work on specific medical device through all life cycle phases. You will leave the workshop with practical experience and be able to apply what you have learned directly to your devices – without any transfer effort.
The practical workshop teaches you the methodology you need to independently evaluate and establish the use of AI. You will benefit from exchanging experiences with other companies, be able to pass on your knowledge to your colleagues, and become a valued driver of digital transformation.
You will learn how to use large language models in accordance with MDR, IVDR, ISO 13485, and the AI Act, thereby meeting all regulatory requirements. With this knowledge, you can feel confident during your next audit and confidently refute objections from authorities and notified bodies – no more fear of non-conformities.
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The workshop covers the following topics:
AI models
Working with LLMs
Application of LLMs in the development and approval of medical devices
Regulatory requirements for the use of AI in product development and approval
By attending the workshop, participants will achieve the following objectives:
This workshop is designed for employees of medical device and IVD manufacturers who are responsible for product development, quality assurance, and regulatory affairs.
These include, for example, individuals in the following roles:
Participants should have basic AI skills and a general understanding of medical device development processes and the product life cycle.
Ideally, participants will already have experience working with technologies and be open to integrating new, innovative AI-based solutions into their everyday work.
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 workshop 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 workshop 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 workshop 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 workshop, 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.
Prof. Dr. Christian Johner is the owner of the Johner Institute and an expert in the development and approval of medical devices that contain or are software. As an auditor, member of a standards committee, trainer for notified bodies, and author of several books and guidelines, he contributes to the further development of the regulatory landscape. His work includes guidelines developed for the WHO and notified bodies. He is also one of the most important contacts for the medical technology industry on AI. He has already created the AI Act Starter Kit and the AI Act E-Learning Course. Christian Johner has taught at several universities, including the University of Applied Sciences in Konstanz, the University of St. Gallen, the University of Würzburg, and Stanford University, where he focused primarily on software architecture, software quality assurance, and medical informatics.
Mario Klessascheck is an electrical engineer (TU) with over 25 years of experience as an embedded developer for active medical devices. As CEO of Johner Institut Schweiz GmbH, he supports companies in the development and approval of safe, standard-compliant medical devices. He is an author, member of standards committees, lecturer, and trainer, and is valued for his comprehensive expertise and practical consultancy in the medical technology industry. Another focus of his work is integrating artificial intelligence into the development processes of medical systems. His expertise includes medical systems engineering and functional safety.
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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