MethodSense CEO Rita King will present insights on strategies to navigate the regulatory landscape for AI/ML-powered medical devices.
Attendees will learn best practices for lifecycle management, clinical validation, and FDA submission readiness to accelerate product clearance and compliance. Through real-world case studies, discover how leveraging robust strategies and tools like LuminLogic can optimize regulatory success and streamline the development of AI/ML medical technologies.
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Rita King has served as a regulator, technologist and professional auditor for more than 30 years, garnering a well-deserved international reputation as a regulatory expert. She holds an MBA from the Fuqua School of Business at Duke University and BS in Electrical Engineering with a minor in Computer Science from NY University (formally Polytechnic University).
Rita has been a participant in numerous national and international committees to develop industry standards and regulations. She is a founding member of the Underwriters Laboratories team that defined, launched, and managed the operations of the first US program to evaluate safety critical software used in commercial and medical devices. Rita also contributed to the development of the ANSI (American National Standard Institute) approved Standard for Safety Critical Software, UL 1998.
Rita is a sought-after speaker and is often published regarding regulatory matters. She remains an active participant of industry associations, where she continues to share her knowledge and experience to further advance the industry.
