A milestone for AI in medicine: Our customer Prof. Valmed® is now CE-certified!
Artificial intelligence is increasingly finding its way into everyday medical practice, but only a few applications manage to meet the high regulatory requirements of a medical device. We at AIQ are all the more proud that our customer Prof. Valmed® has reached this milestone: The innovative AI application for medical professionals is now officially certified as a Class IIb medical device under the EU Medical Device Regulation(MDR, Regulation (EU) 2017/745). A real breakthrough for the use of Large Language Models (LLMs) in clinical decision support!
How Prof. Valmed® supports medical diagnostics
Prof. Valmed® provides physicians and healthcare professionals with validated medical information via a Large Language Model-based application. The AI supports diagnosis and treatment recommendations by accessing 2.5 million validated medical documents from six key categories – including medical guidelines, regulatory documents, PubMed and Cochrane. In this way, Prof. Valmed® enables evidence-based decision-making that makes the everyday work of doctors and medical staff easier.
Our contribution at AIQ: Technical excellence meets regulatory compliance
At AIQ, we develop and test state-of-the-art AI applications based on the principles of Retrieval Augmented Generation (RAG). This means that the Large Language Model not only draws on existing knowledge, but also searches specific medical sources and integrates relevant information in real time. This innovative architecture enables a high level of accuracy, transparency and trustworthiness – essential factors for use in medicine.
A crucial aspect of this success was the close collaboration between our AI Quality & Testing Hub and the team at Prof. Valmed®. Together, we validated the technology, tested its safety and robustness and met the necessary regulatory requirements. The DIN EN ISO 13485:2021 certification confirms that Prof. Valmed® meets the high quality standards for medical devices – a milestone that everyone involved can be proud of!
Regulatory excellence right from the start: The role of VDE and AIQ
A key success factor for the CE certification of Prof. Valmed® was the early integration of regulatory requirements into the development process. A strategic CE roadmap served as a guideline for the entire approval process and ensured that all necessary requirements were taken into account from the outset according to the principle of “compliance by design”.
In order to accelerate the development and approval of innovative AI applications in medicine, the experts from VDE Health and the AI Quality & Testing Hub (AIQ) worked closely with Prof. Valmed®. This close cooperation enabled the implementation of a comprehensive quality management system and the creation of complete technical documentation – two essential prerequisites for successful certification.
The result: Prof. Valmed® is the first AI-supported tool for clinical decision support that has successfully completed CE certification as a medical device in risk class IIb under the EU Medical Device Regulation (MDR). A significant step for the safe and compliant integration of AI into everyday medical practice!
Why this success is special
The combination of technological progress and medical quality is a balancing act that few AI products can master. The fact that Prof. Valmed® was the first product of its kind to successfully overcome these hurdles is proof of the excellence of the entire team.
This success not only shows that AI can be used safely and in compliance with regulations in medicine, but also that AIQ plays a central role in the development and quality assurance of such applications. We look forward to continuing on this path and actively shaping the future of medical AI!
Outlook: The future of AI in medicine
The CE certification of Prof. Valmed® is just the beginning. The integration of AI into everyday medical practice will continue to progress, and with every innovation comes new challenges – be it in terms of reliability, data protection or ethical issues. At AIQ, we are ready to take on these challenges and continue to develop innovative solutions that will change the medical sector for good.
A big thank you to everyone who contributed to this success – especially to the team at Prof. Valmed® for their trusting cooperation. We look forward to the future!