Interested participants from other time zones are welcome to contact us regarding the training at [email protected].
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Artificial Intelligence (AI) is rapidly transforming the medical device industry from diagnostic support to patient monitoring. But innovation must go hand in hand with compliance. The integration of AI technologies into medical devices also introduces complex challenges in terms of safety, performance, and regulatory compliance. With the EU MDR and the upcoming EU AI Act, regulatory expectations for AI-enabled medical devices are becoming clearer and even more demanding so that regulatory bodies are adapting their frameworks to address the unique risks and challenges posed by these technologies.
This training is specifically designed to provide medical device professionals with a practical and in-depth understanding of the regulatory and technical considerations involved in developing and marketing AI-powered medical devices under the EU MDR 2017/745 and the upcoming EU Artificial Intelligence Act (EU AI Act).
This Training covers:
- Understand the regulatory landscape for AI-based medical devices, including applicable requirements under the MDR and the upcoming EU AI Act.
- Explore the EU AI Act and its impact on product development and market access
- Identify risks, transparency, and lifecycle obligations for AI-based technologies
- Identify common pitfalls and challenges in demonstrating conformity for AI-enabled devices.
- Gain insight into DQS-MED’s assessment approaches and notified body expectations for AI-related submissions.
- Case studies, group exercises, and Q&A sessions
Target Audience: This one-day training is ideal for professionals involved in the development, Regulatory & Quality Assurance and conformity assessment of AI-based medical devices, particularly those navigating both the MDR and the upcoming EU AI Act.
Benefit: Whether you are new to AI regulation or looking to refine your current strategies, this training will help you bridge the gap between innovation and rigorous compliance, enabling the safe and successful deployment of AI-driven medical technologies.
Certificate: Participants receive a Certificate of Attendance of DQS MED GmbH
Trainer: Is a highly qualified regulatory expert from DQS MED, a leading Notified Body with deep expertise in conformity assessment under EU MDR.
Auditors
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Andrei Ninu
Auditor
Dr. Andrei Ninu is a regulatory affairs expert specializing in active medical devices, software safety, and AI in healthcare. He leads the Software Operations Group at DQS-MED, bringing together specialized expertise to deliver high-quality assessments for software-based medical devices worldwide. With extensive experience in EU and international regulatory compliance, he focuses on evaluating and ensuring conformity with MDR, the AI Act, and related standards. Holding a Master’s in Control Systems and Robotics and a PhD in Computer Science/Biomedical Engineering, he combines over a decade of software development experience with deep insight into AI-driven medical technologies.