Tuttlingen – More and more manufacturers are discovering the potential of artificial intelligence (AI) for their medical devices, especially machine learning. In order for the idea to become an application, questions about regulatory requirements and validations must be answered. Two seminars by MedicalMountains GmbH, which are offered as part of the AIQNET project, provide tools for this.
Put simply, machine learning means that systems can make decisions autonomously by generating and evaluating data - growing out of themselves in order to better master complex challenges step by step. However, there are currently no specific legal requirements for the use of these processes in medical technology. In addition, manufacturers and notified bodies lack harmonized standards.
Against this background, the Johner Institute has created an AI guide, which Prof. Dr. Christian Johner at the half-day seminar "Develop AI applications in compliance with the law" on May 12. Among other things, he explains how manufacturers can control the risks, especially in machine learning processes, what expectations notified bodies have and how overall approval hurdles can be minimized. At the event, the speaker will also be available for specific questions and assistance.
In order to be able to reliably use AI in safety-critical areas such as medical technology, the question of validation is just as crucial. Prof. Dr. Martin Haimerl from Furtwangen University (HFU) on June 24th. The seminar highlights the special requirements for validations, such as bias factors, data management or environmental influences. Both closed and continuously learning systems are analyzed and discussed. With the approaches obtained in this way and best practice examples, it is explained how the step into the validation of AI-based technologies can be approached.
"We're not talking about what might be someday. AI is present,” emphasizes Britta Norwat, who is responsible for the AIQNET project at MedicalMountains GmbH. "The seminars are door openers for concrete implementation and thus for the technological lead." AIQNET supports you on this path: The project plan develops a digital ecosystem that structures data, links it in a meaningful way and makes it available for AI applications. Above all, small and medium-sized medical technology companies should benefit from this: The stated goal is that they can use the opportunities of AI for themselves and build bridges into the future.
