“Navigating the Intersection of AI, Safety, and Compliance: Strategies for Meeting Regulatory Requirements and Mitigating Risks”
Abstract:
The intersection of AI, safety, and compliance is more important than ever. As companies race to innovate and consumers demand safer products, regulations like the EU AI Act are reshaping the landscape.
In this keynote, Ranj will explore the challenges and opportunities of ensuring compliance for AI systems, particularly high-risk systems. With extensive experience in health and safety standards, he’ll explain how AI risk management, quality management systems, trustworthiness, transparency and cybersecurity can be integrated to meet regulatory requirements.
This session will also explore the unique challenges of assessing and mitigating AI risks, including the testing, and monitoring of AI systems compared to conventional software, to address the unique risks posed by AI systems—particularly those involving nonphysical harms, such as bias and discrimination.
You’ll discover how the integration of horizontal AI standards and industry-specific safety standards—such as those in medical devices and machinery—can work together to shape a more comprehensive and effective compliance strategy.
The session will offer insights into how the AI Act can protect consumers while fostering innovation, and highlight the role of global collaboration in developing flexible and precise AI standards.
Ranj is a recognized software safety and quality leader with 18 years of experience in medical devices, digital health, and health AI. His expertise in medtech and health AI drives pioneering research into integrating AI safety into both new and existing regulatory frameworks.
A key contributor to international AI standards, Ranj actively participates in technical committees like JTC 21 (CEN-CENELEC) and UK's BSI ART/1, shaping the regulatory landscape for the upcoming EU AI Act.
Known for his strong reputation in risk management, software life cycle, and Quality Management Systems (QMS), Ranj distills complex regulatory and design assurance concepts into clear and accessible language, making them understandable to a wider audience.
Addressing the challenges posed by AI to traditional safety assurance and compliance methods, Ranj's recent work focuses on developing measurable and verifiable techniques akin to those used in functional safety. His career highlights include leading software safety and cybersecurity initiatives at Medtronic, Stryker, and Google Health, and advancing compliance with global digital and AI regulations.