Enhancing medical device regulatory compliance through AI-driven risk management strategies
Shahram Ahmadi, PhD
Abstract
The application of artificial intelligence (AI) in medical device risk management could offer significant improvements in regulatory compliance, safety, and operational efficiency. AI technologies, particularly machine learning (ML), can enhance traditional risk management by automating processes and providing real-time analyses of clinical and operational data to identify noncompliance and emerging risks. This integration facilitates predictive analytics, fraud detection, and anomaly detection, ensuring the integrity and cybersecurity of medical devices.
Keywords – artificial intelligence, EU AI Act, EU MDR, FDA, machine learning