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Notified bodies and authorities are increasingly using AI to review technical documentation. This puts manufacturers at an asymmetric disadvantage, as AI-supported review is easier to implement than AI-supported creation. The new MDR and IVDR already allow for the submission of structured data. Those who act now can automate routine tasks with AI, find errors early on and successfully complete the approval process in a timely manner.
Structured data in YAML and JSON massively improves the quality of AI results. However, many employees in regulatory affairs, clinical affairs and quality management feel overwhelmed by this – and are wasting valuable potential.
This workshop is an important prerequisite for our expert seminar on the use of LLM in the development and approval of medical devices. Here, participants must be able to understand and develop YAML and JSON data structures and use them as part of their prompts – precisely the skills you will acquire in this course.
The practical examples and the resulting discussions, as well as the exchange with the other participants, were very helpful for me, as I have no experience from a developer's perspective.
The workshop is tailored for people with no prior technical knowledge. You will have an easy introduction without technical vocabulary and achieve the learning objectives in no time.
The practical examples are taken from the medical device ecosystem. You can reuse many data structures 1:1 for your own work, saving you time right away.
You will learn how to automate repetitive tasks using AI. This will give you back much-needed time for tasks that require human judgement.
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+49 7531 94500 20
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The workshop is aimed at employees of medical device and IVD manufacturers as well as notified bodies who create or review technical documentation in accordance with laws and standards:
Participants can easily follow this workshop even without any special prior knowledge.
After registering, you will receive a confirmation email containing the meeting link, the time and information about the participants.
Within the next 48 hours, you will receive an invoice with a payment term of 14 days. If this payment term is not feasible for your company, please send a short email to [email protected] to find a solution.
Three days before the seminar, you will receive two emails: the first will contain the final link to the seminar and the second will contain the access data for a cloud folder where you will find preparation documents, exercises and presentations.
Our online/remote workshops are conducted using the MS Teams video conferencing tool. We recommend that you dial in 20 minutes before the start of the workshop to resolve any technical issues in good time. Our team is available at any time to answer your questions or help with any problems.
At the end of the workshop, you will receive a feedback link for evaluation. We will send you your certificate of participation the following day.
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.
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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