Availability, accessibility, affordability, and appropriateness are among several factors that significantly affect the adoption and diffusion of medical devices in low- and middle-income countries. Design processes that promote early and frequent engagement with stakeholders may increase the...

The aim of this study is examining Korean In Vitro Diagnostics (hereafter, IVD) companies' catch-up with established medical device companies by analyzing the process of sensing, seizing, and reconfiguration during the Corona Virus Disease 2019 (hereafter, COVID-19) pandemic. The potential...

In an increasingly impacted environment influenced by emerging technologies such as robotics and artificial intelligence, such technologies will also impact the use and control of medical devices. Regulation of such medical devices can adopt regulatory techniques which apply in the field of...

In enacting the Medical Device Amendments of 1976, Congress instituted a flexible system of regulatory controls over a vast array of health care products. Analyzing the complex statute and its legislative history, Professor Leflar finds at the law's core a structure designed to ensure the Food...

While Australia has enjoyed the benefits of a National Medicines Policy (NMP) for many years, there is no national equivalent policy for medical devices. This is despite an established medical device legal framework that spans multiple departments across the Australian Government. The existing...