Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...

The regulatory environment for prescription medical device manufacturers and distributors has become increasingly stringent as state-based ...

The Indian government is considering lowering tariffs on US medical devices to mitigate potential US tariff threats on Indian ...

Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion ...

AI-driven research is making titanium 3D-printing faster, stronger, and more efficient, transforming aerospace and defense ...

Manufacturers monitor input stock, equipment condition, finished product quality, plant noise, energy stability and usage, ...

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...

The global Medical Device Contract Manufacturing market size was $73.61 billion in 2023 and is projected to reach $81.19 billion in 2024. This market is expected to grow significantly, reaching ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

China and Mexico are two of the largest medical equipment manufacturers in the world. The U.S. has imported roughly $10B in medical equipment from China, so far this year, and about $7B from Mexico, ...

Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...

Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...