Use of clinical trials to evaluate the safety and efficacy of medical devices
Vipin kumar Mishra kumar Mishra
Paper Contents
Abstract
Clinical trials are fundamental to assessing the safety and efficacy of medical devices before their commercialization. Unlike pharmaceutical products, medical devices come in various forms and functionalities, which present unique challenges in their evaluation. This article provides a comprehensive review of the methodologies, regulatory frameworks, challenges, and innovations in clinical trials specific to medical devices, with a focus on recent developments between 2020 and 2025.
Copyright
Copyright © 2025 Vipin kumar Mishra . This is an open access article distributed under the Creative Commons Attribution License.