Course objective and outcome
Artificial Intelligence (AI) or Machine Learning (ML) is one of the most innovative technology fields of our time and has already brought revolutionary advances in many industries. AI/ML has already become an important tool within medical devices and is constantly being developed to improve human health. The potential of AI/ML is enormous and ranges from diagnostics and early detection of diseases to the development of drugs and individual treatment plans.
 
You will gain a broad insight into the application of AI/ML in the field of medical devices and develop an understanding of how AI can be used in this field. The content reflects the current legal and regulatory status and is taught in a practical way. This allows you to expand your knowledge and skills to help your company adopt AI technologies with medical devices.
 
The course will focus on:
 

• Introduction to AI/ML
• AI/ML concepts and terminology
• Assessing AI/ML performance
• Assessment of AI/ML systems under the MDR
• The EU AI Act

 Content
The course deals with the use of artificial intelligence for medical devices. AI is considered a transformative technology that offers undeniable added value for medical devices of various categories. In this course you will learn how artificial intelligence is applied in medical devices and what developments can be expected in the future. The course is divided into three parts.
 
The first part deals with the current regulatory requirements for AI/ML supported products and future developments. You will learn about the regulatory approaches that currently exist, the opportunities and risks associated with the use of AI/ML, and how they relate to the existing rules. Regulations such as the EU MDR and IVDR also affect AI/ML based medical devices.
 
In the second part, special attention will be paid to the safety of AI/ML based medical devices. For AI/ML based medical devices, it must be objectively proven that they deliver reproducible and reliable results. While standards and guidelines for regulating AI/ML are still evolving, medical device manufacturers must nevertheless consider the power of AI/ML methods – including verification data, algorithm development, and risk management. Find out what regulatory approaches currently exist and how they relate to each other. You will learn which measures you can integrate into your own processes to develop AI/ML products safely and be better prepared for upcoming regulations.
 
The third part is about QMS – how can AI/ML supported products be optimally developed within the framework of quality management and the product life cycle. It deals with what documentation is necessary and what responsibilities are to be borne in the company.
 
Each section will conclude with a short group exercise.
  
Who should attend?
The course is relevant for medical device professionals who are already using AI/ML methods or are planning to do so, in particular:
 

• Security for medical device manufacturers
• Regulatory Affairs
• Quality
• System and software engineering
• Requirements Engineering
• Project
• Risk management
• Product
• Management
• Software Consultants

 
There are no prerequisites for participation, however, a general understanding of how medical devices are regulated under the MDR is an advantage.
 
Trainer
Christian Jensen, TÜV SÛD Tutor