MethodSense announces its participation as an exhibitor at the American Medical Device Summit (AMDS) 2025 in Chicago, IL, 27-28th October 2025.
As part of this year’s distinguished conference lineup, Rita King, CEO of MethodSense, will deliver a feature presentation on ‘Navigating FDA and EU Regulatory Landscapes for AI in Medical Technologies: Challenges and Strategies for Manufacturers, Regulators, and Stakeholders.’
Feature presentation at AMDS 2025
27th October 2025, 12:15pm-12:45pm 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, harmonising documentation and processes, and preparing for significant EU deadlines in 2027
- How MethodSense’s LuminLogic eQMS and compliance management platform helps organisations 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.”
