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 ...
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Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Although most manufacturer reports of medical device adverse events are reported on time, a considerable proportion are submitted late.
AI-driven research is making titanium 3D-printing faster, stronger, and more efficient, transforming aerospace and defense ...
Shenni Holdings plans a $15M IPO to expand in third-party medical devices. Learn about their growth, risks, and valuation ...
Intel: At a town hall meeting following his appointment as CEO last week, he told employees that the company will need to ...
Manufacturers monitor input stock, equipment condition, finished product quality, plant noise, energy stability and usage, ...
The Committee pointed out that several medical device manufacturers are hesitant to set up units in India due to the delaying ...
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
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 ...
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