A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. By Bob Mehta I have always experienced great difficulty in ...

The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, ...

Defective medical devices — and the lack of laws or enforcement against them — have killed thousands of patients around the world and put millions more at risk. Yet, in my country and many others, few ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Objective Medical devices account for approximately 6–10% of national health systems’ carbon footprints. The global use of single-use devices has increased, with implications for health systems’ ...