Skip to content
Research Article Open access CC BY 4.0

Post-Market Surveillance of Medical Devices Using AI

Tushar Khinvasara, Nikolaos Tzenios, Abhishek Shankar

Journal of Complementary and Alternative Medical Research · pp. 108–122 · Published 29 Jun 2024

10.9734/jocamr/2024/v25i7552

Abstract

Artificial intelligence (AI) has emerged as a transformative tool in post-market surveillance (PMS) for monitoring the safety and performance of medical products. This article explores the role of AI in optimizing PMS practices, focusing on its applications in signal detection, risk assessment, and regulatory compliance. By harnessing machine learning algorithms and big data analytics, AI facilitates the automated analysis of real-world evidence, including patient outcomes data, adverse event reports, and electronic health records. Through pattern recognition and anomaly detection, AI algorithms enable the early identification of potential safety issues and facilitate timely interventions to mitigate risks. Moreover, AI-driven PMS systems enhance regulatory oversight by providing regulators with comprehensive and actionable insights into product safety profiles and emerging trends. However, concerns regarding data privacy, algorithm bias, and interpretability underscore the need for transparent and ethically responsible AI deployment in PMS frameworks.

PMS (Post-Market Surveillance) artificial intelligence medical devices healthcare

Cited by 27

Comprehensive overview of AI methodologies in nano-drug delivery Optimization and Design

Lei Zhang, Jun Li, Muzian Li · npj Precision Oncology · 2026

Artificial intelligence–driven transformation of healthcare systems: methods, applications, and future perspectives

S. Mishra, H. Mamoudou, K. Gurung · Archives of Computational Methods in Engineering · 2026

Ai-Driven Digital Quality and Compliance: Transforming GXP Systems in Life Sciences through Intelligent Automation

Jaidev Jayakumar · International Research Journal on Advanced Engineering Hub (IRJAEH) · 2026

The impact of integrating artificial intelligence into regulatory affairs functions in the Medtech industry

R. Cotta, Mary Garvey, Olivia McDermott · Expert Review of Medical Devices · 2026

Fast and Precise: AI Medical Devices at the Intersection of Speed and Accuracy

R. Seth, Manju Nagpal, R. Swami · Current Pharmacology Reports · 2026

SERS Meets Artificial Intelligence: A New Frontier in Cancer Diagnosis and Prognosis.

Noor Ul Huda, Rana Zaki Abdul Bari, M. A. Javed · Analytical Chemistry · 2026

Article metrics

Real usage data collected on this platform.

0

Page views

0

PDF downloads

0

Outbound clicks

27

Citations

Views by country

Approximate, from request IP at view time — not citizenship or institution. Countries with fewer than 5 views are grouped as "Other".

No views recorded yet.

Traffic sources

Referring site, by host.

No traffic recorded yet.

Views and downloads exclude known bots/crawlers. Citations combines this platform's own DOI-resolved index with each external source's own reported total — see Cited by above for individually listed citing works. Last refreshed 0 seconds ago.