Based on industry statistics, it is obvious that intensified regulatory scrutiny has become a harsh reality for medical device manufacturers. Over the last several years, medical device companies have been hit with injunctions, undergone product recalls, or found themselves operating under FDA consent decree. FDA regulations seem to impact every step of the medical device lifecycle, from properly classifying a device and developing a regulatory strategy to preparing FDA submissions.
Interesting article on the growth and advancement in technology to manage data and improve compliance through software solutions!
Marion manufacturer branches out making medical devices Ocala A Marion County manufacturer of parts for car and boat racing engines stands on the verge of expanding a spinoff medical devices company whose flagship product aims to accelerate...
Boat engine company gets into manufacturing medical devices.
(HealthDay)—Approval by the U.S. Food and Drug Administration does not necessarily mean that a medication or medical device has received a grueling trial by fire and has been proven safe beyond all doubt, according to a trio of new studies...
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