ABSTRACT

The synergy of Artificial Intelligence and Medical devices has transformed healthcare, yielding unprecedented opportunities for improved patient outcomes. The integration of AI needs a drastic challenge because of the guidelines framed following traditional medical devices. Navigating these regulatory considerations for AI-MD requires a detailed understanding of regulatory guidelines and technological progress. This article explains the portfolio of AI- integrated devices, spotlighting the major regulatory requisites such as quality, safety, and efficacy. Recognizing the growing demand for AI-enabled medical devices, organizations are taking steps toward achieving their promise. AI has improved operational efficiency, individualized patient care, and increased diagnostic precision in medical equipment, all of which have revolutionized the healthcare industry. The necessities of the regulatory guidelines considering AI have also been discussed concerning various regulatory authorities like the Food and Drug Administration (FDA), and European Medicines Agency (EMA-MDR) followed by ISO and IEC. Keywords: Medical device, regulatory compliance, artificial-intelligence, machine learning, regulatory framework
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9603.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9603