This seminar helps you develop medical device software that uses artificial intelligence (AI) methods in compliance with the law and bring it to market as quickly as possible – even though the regulatory requirements are still unspecific.
You will first be introduced to artificial intelligence and machine learning, learning the basics and most important terms. We will then show you the regulations, directives, and standards relevant to European and US manufacturers. You will also learn which procedures and methods best meet the respective requirements.
The group work based on the example, the resulting discussions, and the exchange with the other participants were very helpful for me, as I participated from a QM perspective but have no experience from a developer's point of view.
Through various workshops and exercises, you will learn how to make your software development not only legally compliant but also efficient. In small groups, you will use a consistent example to work out how the technical documentation for an AI-based medical device must look to meet regulatory requirements.
Our lecturers have a deep understanding of both the regulatory and technical aspects and are always up to date despite the rapid development of regulations in the field of AI. They have extensive experience supporting manufacturers of AI medical devices and developing AI software and can, therefore, provide precise answers to your questions.
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.
Phone
+49 7531 94500 20
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The seminar covers the following topics:
After the seminar, you will be able to:
The target group is heterogeneous and typically divided into two areas: technology or quality management/regulatory affairs.
Typical participants include:
Knowledge of AI is not necessary, but a basic technical understanding is required. Regulatory knowledge is helpful but not essential.
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. Oliver Haase has a rare combination of in-depth regulatory and technical knowledge. He knows the ins and outs of regulatory requirements, the expectations of notified bodies, and the typical pitfalls and traps in developing and documenting AI-based medical software. With his many years of experience in approving AI-based medical devices, he can help you navigate the regulatory jungle with a sense of proportion.
Kai Haase combines technical know-how with practical expertise in AI-based medical devices. He holds a master's degree in computer science from the Albert Ludwig University of Freiburg, internationally renowned for its research in machine learning. He specialized in medical image processing while still a student. Since then, he has been helping manufacturers of medical devices validate their AI systems for regulatory compliance. His passion for AI in medical technology and his deep understanding of regulatory requirements make him a valuable companion for anyone who wants to bring AI systems to market and comply with regulations successfully.
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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