Seminar "AI Act for Medical Device and IVD Manufacturers"
AI Act meets MDR/IVDR: Implementing regulatory requirements in a legally compliant and efficient manner
This intensive seminar provides you with the necessary know-how to apply the AI Act (not only) for your medical and IVD medical devices in a legally compliant manner and to integrate it efficiently into your existing regulatory processes (MDR/IVDR) – from classification to practical implementation.
Gain legal certainty for upcoming audits and inspections
The seminar shows you how to correctly qualify and classify your devices
– the basis of all legally compliant documentation. You will work with the Team NB AI guideline and carry out practical exercises on device classification and gap analysis so that you can identify non-conformities
and remedy them in a targeted manner.
100%
of the participants who gave feedback
recommend this seminar!
Document correctly once instead of twice: How to meet the requirements of the AI Act and the MDR/IVDR at the same time
You will learn how the AI Act and MDR/IVDR work together optimally and create lean documentation that complies with all EU regulations at the same time. No more redundant or contradictory documents: You will receive precise specifications for a maintainable QM system that complies with both regulations.
Clear planning and reliable budgets for your AI Act implementation project
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.
Prove your AI competence – with a certificate
The practice-oriented seminar ends with a voluntary online exam (duration: approx. 20 min). Upon passing this exam, you will receive a certificate that proves your AI competence in accordance with the legal requirements of the AI Act. This way, you not only have the knowledge but also documented proof for audits and internal requirements.
You can find more information about the seminar and the schedule in the information sheet:
Further Information
- 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
- 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.
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
- 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
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 seminare@johner-institut.de to find a solution.
Three days before the seminar, 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.
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.
Get to know your trainer
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.
Are you familiar with our in-house seminars?
We are also happy to offer you our seminars as in-house seminars. Either online or at your premises, as required.
Please feel free to contact us.
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