Rita King is a regulatory strategist, technologist, and professional auditor with more than 35 years of experience supporting the medical device and regulated technology industries. She holds an MBA from the Fuqua School of Business at Duke University and a BS in Electrical Engineering with a minor in Computer Science from New York University, formerly Polytechnic University.
Rita has participated in numerous national and international committees focused on the development of industry standards and regulations. She was a founding member of the Underwriters Laboratories team that defined, launched, and managed one of the first U.S. programs to evaluate safety-critical software used in commercial and medical devices. She also contributed to the development of the ANSI-approved Standard for Safety Critical Software, UL 1998.
Rita is the Founder and CEO of MethodSense, a regulatory and quality consulting firm supporting medical technology companies from innovation through commercialization, and Founder of LuminLogic®, an AI-enabled regulatory compliance and quality management platform developed from decades of real-world regulatory experience. Through MethodSense and LuminLogic, Rita and her teams have supported thousands of successful regulatory, quality, and commercialization initiatives across the medical device industry.
She is a frequent speaker and published contributor on regulatory and quality topics and remains actively involved in industry associations and initiatives advancing medical device innovation, quality systems, and regulatory strategy.
Join Rita King, Founder and CEO of MethodSense, Inc. as she discusses the practical realities of medical device design across the product lifecycle. King, a medical device regulatory expert with 35 years of hands-on experience will share strategies for maintaining connected decisions, continuous traceability, and evolving regulatory strategy to ensure designs hold up from prototype through market release.
Drawing from real-world submissions, audits, and product challenges, King will examine why well-engineered decisions made early in development are often challenged under regulatory review, not due to poor engineering, but due to disconnects between design choices and downstream requirements. The session covers critical areas including cybersecurity architecture, AI regulatory pathways, clinical evidence expectations, and human factors integration. It will also explore how funding pressures, regulatory complexity, and siloed team operations create predictable gaps and how a more connected lifecycle approach can help teams anticipate and manage them.