Lessons Learned from the Development and Approval of an AI-Based Medical Device
Developing an AI-based medical device presents teams with particular technical, regulatory and organisational challenges. But even after successful development and approval, important questions remain: How can such a product be operated safely and in compliance with regulations in the long term? And how can new regulatory requirements be integrated into existing processes?
In the next KIMed Network Impulses series, “Lessons Learned – Development and Approval of an AI-Based Medical Device”, Florian Bontrup, Managing Director of DOCYET GmbH, will provide practical insights into the development and approval of an AI-based medical device. Drawing on his practical experience, he will take a closer look at the challenges that played an important role throughout the project.
The focus will be on concrete lessons learned: What were the biggest challenges? Which decisions proved successful, and what would the team do differently from today’s perspective? The webinar will also highlight which experiences and insights can be transferred to future projects involving the development of AI-based medical devices.
Another focus will be on the ongoing operation of the product: New regulatory requirements, such as those introduced by the EU AI Act, create additional obligations for providers and operators of AI systems. The webinar will therefore also address how such requirements can be integrated into the operation of an already approved AI-based medical device in a practical and meaningful way. There will be plenty of time for questions and discussion afterwards.
At a glance
Date and time: 6 October 2026, 5:00–6:00 pm
Location: Via Zoom | Registration link: https://uni-leipzig.zoom-x.de/j/5338264710?omn=66027714535
Speaker: Florian Bontrup, Managing Director, DOCYET GmbH
The webinar is aimed at anyone involved in the development, approval and operation of AI-based medical devices who would like to benefit from practical experience gained from a project that has already been implemented. The webinar will be held in German.
There is no registration required; participation is free of charge.
About KIMed Network Impulses
With our “Network Impulses” webinar series, we bring together interdisciplinary stakeholders working on the use of artificial intelligence in medicine. In short keynote presentations, experts from academia and industry share their projects, experiences and questions – ranging from the development of new AI solutions to their application in everyday clinical practice.
The subsequent moderated discussion provides an opportunity for questions, exchange and new perspectives.
Learn more about knowledge transfer within KIMed here.