Clinical Evidence and Regulation for Medical Devices and IVDs with AI and Digital Health

This year, we are excited to merge two distinguished conferences: the Conference on Clinical Studies with Medical Devices and IVDs (CSMD) and The International Conference on Clinical Investigations, Regulation, and Market Access for Medical Devices and IVDs (Horizon). By combining these events, we will focus on the rapidly evolving landscape of AI, digital health, and software—exploring their impact on clinical evidence and regulatory strategies.

As AI and digital technologies continue to reshape healthcare, the need for clear regulatory frameworks and reliable clinical data has never been more crucial. This conference will address the intersection of clinical studies and regulatory affairs, specifically focusing on the challenges and opportunities presented by AI and digital health innovations.

Our program will delve into key issues at the intersection of AI, software, and medical devices, providing valuable insights into both current challenges and future opportunities.

Topics include:

• Defining clinical evidence requirements for digital health products from the perspectives of patients, payers and regulators.
• Navigating the evolving AI landscape in medical devices—striking the right balance between innovation, risk and patient access.
• Overcoming challenges in clinical study design for software-based devices, with a focus on improving patient engagement and data quality.
• Ethical Considerations & Bias in AI – Addressing fairness, transparency, and bias in AI-driven medical devices.
• Real-World Evidence & Post-Market Surveillance – How AI and software updates impact long-term safety, effectiveness and regulatory compliance.
• Exploring regulatory best practices and the potential role of AI in enhancing and streamlining clinical investigations and approval pathways.

Our distinguished speakers will present practical examples, provide strategic insights, and offer solutions to the challenges faced by professionals in the fields of clinical affairs, regulatory affairs, R&D, verification and validation .

The event is designed for regulatory and clinical leaders in the medical device and IVD industry. Meet your colleagues and distinguished experts in clinical trials, reimbursement, regulations, and data management to share your thoughts, discuss hot topics and learn from each other.

We look forward to seeing you in Brussels for an engaging and insightful exchange of ideas.

Sincerely,