Clinical Studies with Medical Devices (CSMD) - Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence

Clinical Studies with Medical Devices (CSMD)-Horizon Special Conference for MedTech AI and Digital Health: Regulation, Market Access and Clinical Evidence is organized by Bioevents and will be held from Nov 04 - 05, 2025 at Sheraton Brussels Airport Hotel, Brussels, Brussels, Belgium.

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.