Implement the Ai Act and MDR/IVDR: This seminar provides you with a structured overview of the regulatory requirements for AI-based medical devices and IVDs. You will learn how to qualify and classify your products in accordance with the AI Act, systematically integrate the requirements into existing MDR/IVDR processes, and establish lean, audit-ready documentation.
This seminar will show you how to properly qualify and classify your AI-based medical devices and IVDs in accordance with the AI Act—as the foundation for a robust regulatory strategy and legally compliant documentation. Using practical examples and exercises, you’ll learn how to implement the requirements of the AI Act, MDR, and IVDR step by step: from the intended use through requirements for the risk and quality management system to the technical documentation.
“What I particularly liked about this seminar was its practical relevance, its focus on the essentials, and the personalized way questions were addressed. It helped me clarify some very important points!”
You’ll learn how the AI Act and the MDR/IVDR are related in substance and how to expand existing processes and documents in a targeted manner, rather than building new structures in parallel. This will enable you to create a streamlined AI file that complies with both regulations—without redundancies, contradictions, or unnecessary additional documents.
You will receive specific tools for your project planning, enabling you to approach your implementation project in a structured manner. After the seminar, you will know exactly what resources you need and will be able to budget costs reliably – no more unpleasant surprises.
At the end of the seminar, there will be an optional online exam (duration: approx. 20 min). If you pass this exam, you will receive a certificate in addition to your certificate of participation. This certificate documents the knowledge you acquired during the seminar and helps you demonstrate your AI competence in accordance with Article 4 of the AI Act.
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In this seminar, you will learn how to properly classify, develop, and document your AI-based medical devices and in vitro diagnostic devices in accordance with regulatory requirements
By attending this seminar, participants will achieve the following objectives:
This seminar is intended for employees of medical device and IVD manufacturers who develop, document, or conduct regulatory assessments of AI-based products.
These individuals typically work in the following areas:
Sie profitieren optimal von diesem Seminar, wenn Sie folgende Voraussetzungen mitbringen:
Kenntnisse von MDR und IVDR
Grundverständnis des Risikomanagements nach ISO 14971
Vorkenntnisse zu KI sind hilfreich, aber nicht erforderlich
Vorkenntnisse zum AI Act sind hilfreich, aber nicht erforderlich
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.
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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