Artificial Intelligence (AI) in Medical Technology

• Specialists and executives from medical technology and manufacturing companies
• Specialists in the areas of security, regulatory affairs and quality management
• Specialists in system, software and requirements engineering
• Project and product managers
• Service providers, suppliers and consultants in the field of medical software

Artificial intelligence (AI) in medical technology describes the use of machine learning methods in medical devices to support diagnostics, early detection and therapy decisions. The seminar "Artificial Intelligence in Medical Technology" provides a sound understanding of the use, functioning, and regulatory framework of AI systems in medical devices. In the training, you will learn how MDR, IVDR, EU AI Act and FDA expectations shape development. You will also deal with the data, risk analysis and quality management requirements of AI in medical devices. You will receive a practical overview of Good Machine Learning Practice (GMLP), verification & validation, and key security and data management requirements. Examples from companies illustrate how products in medical technology can be developed safely and comprehensibly with the help of AI.

Please note this course is run by TÜV SÜD Akademie GmbH.

• How AI systems work
• Classification of AI systems
• Examples of artificial intelligence in medical technology
• Regulatory requirements: MDR, IVDR, EU AI Act, FDA
• Risk management, safety and security for AI-based systems (ISO 14971, BS/AAMI 34971:2023)
• Data quality, logging and transparency in the AI lifecycle (ISO/IEC 24970)
• GMLP in QMS and Life Cycle
• Verification & Validation (V&V) for AI Systems
• Usability and transparency
• Other relevant regulations (including a. ISO 13485, IEC 62304, Guidance MDCG 2019-11, IMDRF)

• You understand the regulatory requirements (MDR, IVDR, EU AI Act, FDA).
• You will get to know GMLP throughout the entire product life cycle.
• They identify risks, data requirements and security aspects quickly and well-founded.
• They are familiar with process and documentation requirements in order to develop AI-based medical devices in a comprehensible and audit-proof manner.
• You will receive practical examples from medical technology and pharmaceutical technology.

Upon completion you will receive your globally recognised TÜV SÜD Certificate of Attendance in Artificial Intelligence (AI) in Medical Technology.

TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.

The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.

In case of any questions or uncertainties, please do not hesitate to contact us.

The seminar will be conducted by an expert with many years of practical experience in the medical technology industry. It conveys complex regulatory requirements in a clear and practical way.