MethodSense CEO to Present at American Medical Device Summit 2025
Presentation on AI Regulation in Medical Technologies for Manufacturers, Regulators and Stakeholders
Feature Presentation at AMDS 2025
Monday, October 27, 2025, 12:15 pm – 12:45 pm CST, Room 1
Navigating FDA and EU Regulatory Landscapes for AI in Medical Technologies
Rita King’s session will highlight:
• The latest regulatory frameworks and guidance from the FDA and the European Union, with a focus on AI-enabled medical devices and software.
• Practical comparisons of risk classification, transparency, technical documentation requirements, and post-market monitoring.
• Unique provisions under the EU AI Act, including fundamental rights evaluations, SME regulatory sandboxes, and obligations for general-purpose AI systems.
• Strategic recommendations for dual compliance, harmonizing documentation and processes, and preparing for significant EU deadlines in 2027.
• How MethodSense’s LuminLogic® eQMS and comprehensive compliance management platform helps organizations efficiently manage compliance, documentation, risk management, and quality assurance in a rapidly shifting environment.
“MethodSense continues to support global medical device manufacturers with technology-driven services designed to create intrinsic value and ensure regulatory success,” said Rita King, CEO of MethodSense. “Attendees will gain clarity on aligning with evolving rules, practical steps for compliance, and how regulatory changes will impact business planning and submissions for AI-powered medical technologies.”
Visit MethodSense in the AMDS Exhibit Hall to discuss solutions for AI-enabled product compliance, quality management, and process control.
For more information or to arrange a meeting during the conference, contact MethodSense at info@methodsense.com.
About MethodSense
MethodSense is a regulatory and quality consulting firm specializing in the medical device and life sciences industries. With deep expertise in FDA, EU MDR, and global regulatory pathways, MethodSense helps companies achieve compliance, accelerate market entry, and ensure product quality. Its LuminLogic® compliance management platform integrates regulatory processes, quality management, and lifecycle documentation into a seamless solution for achieving regulatory success.
Karl von Gunten
MethodSense
kvongunten@methodsense.com
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Distribution channels: Electronics Industry, Healthcare & Pharmaceuticals Industry, Science, Technology
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