Date: 29 January 2026
Time: 16:00 - 17:00 CET | 10 - 11 am EDT
Location: Virtual
Introduction
Artificial Intelligence (AI) is quickly transforming the MedTech landscape. Generative models and large language models are becoming part of clinical evaluation workflows, while AI-driven diagnostic and therapeutic technologies continue to reshape patient care. As manufacturers explore these possibilities, they also face new responsibilities for demonstrating safety, performance, and reliability.
These advances raise important regulatory questions. How do AI-enabled devices fit within the MDR and IVDR? What evidence does a Notified Body expect when algorithms evolve over time? And how will the EU AI Act influence your technical documentation, clinical evaluation strategy, and overall compliance approach?
Bringing an AI-based device to market requires more than strong technical capabilities. It demands a clear understanding of data quality, cybersecurity, algorithm transparency, model drift, and risk management, including how generative and LLM-supported processes contribute to clinical evidence.
Join Qserve experts and Notified Body TÜV SÜD for a practical, live webinar. We will unpack the regulatory expectations, explain what TÜV SÜD assesses during a submission review, and share examples from real-world cases, including those involving AI-supported clinical evaluation activities. You will gain a clearer view of how to prepare your documentation and how to navigate the path toward real-world cases, including those involving AI-supported market approval.
The session features a 45-minute informal presentation followed by a live Q&A. You can submit your questions through the registration form, by email at marketing@qservegroup.com, or directly during the event.
Agenda
- Welcome & Introduction
- Part 1: Introduction to AI in the Regulatory Landscape and What is Needed to Bring Your AI Product to Market?
- General processes and frameworks (MDR/IVDR & AI Act)
- Key Pillar 1: Integrating Cybersecurity by Design
- Key Pillar 2: Robust Data Management & Validation
- Part 2: The Notified Body Review: What We Look For
- Focus on Risk Management (ISO 14971) for AI-driven devices
- Role of the Notified Body Questionnaire in Submissions
- How the Notified Body is preparing for the AI Act
- Part 3: AI Tools
- Insights for AI tools for manufacturers
- Insights for AI tools by Notified Bodies
- Live Q&A
Learning Objectives
After this webinar, attendees will be able to:
- Understand the current regulatory landscape for AI under the MDR/IVDR.
- Gain insight into a Notified Body's perspective on AI, risk management, and clinical validation.
- Learn from case studies about common pitfalls and best practices in AI submission documents.
- Hear how Notified Bodies like TÜV SÜD are preparing for the forthcoming AI Act.
Presenters
We are excited to have Coenraad Davidsdochter, Software and AI Expert at Qserve, and Bingshuo Li, Active Medical Devices Expert at Qserve, as presenters in our upcoming webinar. With their extensive experience, they combine deep neuroscience and neurotechnology insight with more than two decades of software, AI, and quality systems expertise, guiding innovators in developing compliant medical devices supported by solid technical documentation, risk management, and clinical evidence.
We invited guest speaker Marco Caproni, Global Director SW Product Assessment at TÜV SÜD to join the webinar.
Who Should Attend?
This webinar is designed for medical device professionals involved in product development, quality, and regulatory strategy, including:
- Regulatory Affairs Managers and Specialists
- Quality Assurance Managers and Engineers
- R&D Engineers and Project Managers (especially those in software development)
- Product Managers responsible for AI-driven devices
- Clinical Affairs Specialists
- Data Scientists and Cybersecurity experts in MedTech
- Start-up Founders and CTOs in the digital health space.