Solutions Circles Know Before You Go: • Tickets are required and can be picked up at the Solutions Circle check-in desk 20 minutes before start (first-come, first-served). • Max 30 participants per session. Seats cannot be held in between sessions. • Arrive early. Your seat is only held for 3 minutes after a session starts, then released to standby attendees. • Open to full conference registrants only - have your badge ready. • Located in the Exhibit Hall, booth 200.
Description: As Artificial Intelligence (AI) technologies, including machine learning (ML), deep learning (DL), and large language models (LLMs), continue to revolutionize medical device capabilities, they introduce unique risks that challenge traditional regulatory and risk management frameworks. These technologies bring challenges such as data drift, model bias, and cybersecurity vulnerabilities, which require tailored strategies to ensure device safety and effectiveness.
This Solution Circle invites participants to collaboratively explore these novel risks and their implications across the Total Product Lifecycle (TPLC). The discussion will emphasize the critical role of intended use in informing safety risk determination and in shaping regulatory and risk management strategies for AI/ML/LLM-enabled devices. Participants will analyze the evolving regulatory landscape, identify practical approaches to managing transparency and ethical concerns, and develop strategies for continuous monitoring and real-world performance tracking. This interactive session will also address balancing pre-market and post-market considerations to meet both regulatory and quality system requirements.
Learning Objectives:
Gain a comprehensive understanding of how the intended use of AI/ML/LLM-enabled devices shapes safety risk determination and informs regulatory decision-making.
Develop actionable strategies to address challenges unique to AI-driven devices, such as model drift, bias, and hallucinations, ensuring effective and adaptive risk management.
Learn how to integrate the Total Product Lifecycle (TPLC) approach into regulatory and risk management strategies for enhancing monitoring, real-world performance tracking, and long-term safety and effectiveness.
