Regulations

The medical device industry has been facing significant manufacturing challenges, particularly since 2020. Rising costs of parts, labor, and facilities, coupled with stringent regulations, have created a bottleneck that hampers production efficiency. This article explores whether 3D printing can

The recent announcement by the FDA concerning the potential high-risk issue with Fresenius Kabi’s Ivenix large-volume infusion pumps (LVP) has raised important questions regarding the adequacy of safety measures in medical device usage. The initial alert followed a company communication from F

The COVID-19 pandemic brought about unprecedented changes in many aspects of healthcare, including the treatment of opioid use disorder. One of the most significant changes was the relaxation of regulations around the prescription of buprenorphine, a medication approved by the FDA for treating

The recent proposal by the FDA to ban the use of electric shock devices has sparked a significant debate among autism advocates and the public. This issue is especially pronounced at the Judge Rotenberg Educational Center near Boston, where such devices have been used on students. The prolonged

The topic of elderly care is becoming increasingly significant as recent incidents have raised concerns about the safety and well-being of seniors in various eldercare facilities across the United States. This comprehensive analysis focuses on the safety issues in assisted living and nursing homes,

The UK's healthcare regulatory framework is undergoing significant changes, with the General Medical Council (GMC) set to include Physician Associates (PAs) and Anaesthesia Associates (AAs) within its scope of regulation starting December 2024. This expansion represents a noteworthy shift in