Srividya Narayanan
Biography
Srividya Narayanan is a Regulatory Affairs and Compliance Specialist based in Boston, MA, with over two years of experience in medical device regulations, FDA 510(k), ISO 13485, and EU MDR compliance. She currently serves as a Regulatory Affairs Researcher at Freyr Solutions, where she conducts global regulatory research, supports RIMS integration, and contributes to AI-powered compliance tools for medical device submissions. Previously, as a Regulatory Compliance Co-op at Culture Care Collective, she streamlined documentation workflows, reducing compliance preparation time by 30%, and ensured full HIPAA and HITRUST compliance. With prior clinical experience in dental technology and quality systems management, she has maintained regulatory documentation aligned with 21 CFR 820 and ISO standards. Srividya holds an M.S. in Regulatory Affairs from Northeastern University (GPA 3.8/4.0) and an M.D.S. in Periodontics and Implantology from Tamil Nadu Government Dental College (GPA 3.7/4.0). She is also the founder of Regulatory Navigator, an AI-driven compliance platform serving professionals across 50+ countries, and co-founder of Path2RAQA, focused on advancing regulatory affairs education and efficiency.
Research Interest
Regulatory Affairs for Medical Devices and Digital Health, Artificial Intelligence in Regulatory Compliance, Digital Health & Software as a Medical Device (SaMD), Quality Systems and Risk Management in Healthcare, Global Regulatory Convergence, Clinical Workflow Optimization and Compliance Automation.
Abstract
Implementing Robust AI Governance Frameworks for Healthcare: Integrating Standards, Policy, and Continuous Compliance: The rapid adoption of artificial intelligence (AI) in healthcare demands comprehensive governance structures to ensure patient safety, regulatory compliance, and ethical practice. This paper presents a step-by-step framework for establishing AI governance in medical settings, beginning with the formation of a multidisciplinary oversight committee and the identification of applicable regulations (e.g., FDA SaMD guidance, EU MDR/IVDR, IEC 62304, ISO 14971, HIPAA/GDPR). A systematic risk assessment evaluates data quality, algorithmic fairness, cybersecurity, and clinical impact. Formalized policies and standard operating procedures address documentation, change management, and incident reporting. Rigorous data governance and privacy controls safeguard protected health information, while targeted training equips regulatory, development, and clinical teams. Continuous monitoring?including post-market surveillance, performance KPIs, and periodic audits?feeds into an iterative improvement cycle, ensuring governance processes evolve alongside technological and regulatory changes. This framework offers healthcare organizations a structured pathway to deploy safe, effective, and compliant AI solutions.
