One of the primary functions of law is to ensure that the legal structure governing all social relations is predictable, coherent, consistent and applicable. Ta

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health