Seminar "AI Act for Medical Device and IVD Manufac­turers"

In this seminar, you will learn how to develop and operate your AI-based medical and IVD medical devices as well as other systems in compliance with the law: 

• Determine the scope of application: Check whether your devices and systems fall under the AI Act 
• Basics and classification: Correctly classify AI systems according to risk classes
• Manufacturer requirements: Know and fulfill additional requirements for technical documentation and QMS for MDR/IVDR 
• Risk management: Identify and control AI-specific risks, including fundamental rights risks 
• Operator responsibility: Operate AI systems such as medical devices and tools such as ChatGPT in a legally compliant manner in a corporate context 
• Practical implementation: Supplement standard operating procedures and work instructions and perform gap analyses 
• Time planning: Plan projects and implementation, taking into account transition periods 
• Team qualification: Determine competence requirements and training needs

By attending the seminar, participants will achieve the following objectives:

• They can decide whether their medical or IVD medical devices fall under the AI Act (qualification). If so, they can determine the risk class for their devices (classification). Participants can work with the "Commission Guideline" on qualifying AI systems in this context. 
• They are familiar with other typical areas of application for AI in their companies and can assess their use from a regulatory perspective, for example, which legal requirements they fall under (e.g., AI Act, MDR, ISO 13485, ISO 14971), and can carry out qualification and classification for them. 
• The participants are familiar with the structure of the AI Act, know its classifications, and can navigate the legislation confidently and identify relevant requirements. For example, they can assess when the requirements for "GPAI" and for the special AI systems in accordance with Article 50 must be considered. 
• As a result, they are familiar with the different requirements of the AI Act for manufacturers and operators of AI systems that must be considered in the various life cycle phases (research, development, conformity assessment, sale, and post-market surveillance). 
• They can identify where and how the requirements of the AI Act go beyond the requirements for medical and IVD medical devices, where they complement each other, and where they contradict each other. 
• They know which specification documents, such as standard operating procedures, templates, and checklists, they need to create or adapt and how much effort this will require. 
• They can perform gap analyses and identify non-conformities, in particular gaps and inconsistencies in their technical documentation and their QM system, and apply the guidelines of the notified bodies. 
• They can expand the risk management file to include fundamental rights risks.

This seminar is designed for employees of medical device and IVD manufacturers who develop AI-based devices or use AI in their company, for example in development or other regulatory-relevant processes. 

These individuals are typically employed in the following areas: 

• Regulatory Affairs 
• Development, including Data Science 
• Risk and Quality Management 
• Product Management, Clinical Affairs, and Post-Market Surveillance 
• IT
• Legal & Compliance

You will benefit most from this seminar if you meet the following requirements: 

• Knowledge of MDR and IVDR 
• Basic understanding of risk management according to ISO 14971
• Knowledge of AI is optional 
• Knowledge of the AI Act is optional

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.