FDA Inspection Seminar: Preparations for Pharmaceutical and Medical Device Professionals (ON-DEMAND)
This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical ... biologics and ...
Medical Device Network on MSN7d
FDA tags Medtronic embolisation device recall as Class IThe US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as ...
Medical Device Network on MSN5d
FDA tags Becton, Dickinson and Company infusion software recall as Class IProblematic software has been the cause of multiple infusion pump recalls in the medical device industry over the past few ...
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
Medical Device Network on MSN13d
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 ...
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 ...
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
The FDA recall affects more than 25,000 of the Fridley-run company’s devices and follows reports of 17 injuries.
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